{ "schemaVersion": 1, "study": "fda-china-device-enforcement", "measuredOn": "2026-08-28", "question": "When a China-based device firm's product is recalled in the United States, what does the public record show?", "source": "openFDA device enforcement endpoint (public, no auth), search country:\"China\", all pages retrieved", "samplingFrame": "Every device enforcement record openFDA returns for a recalling firm located in China as of the measurement date (264 records); census, no sampling", "readThisFirst": "A recall is a corrective action that happened, not proof of a bad supplier. A firm that never recalls may simply never have detected or reported anything. These counts describe the record, not supplier quality, and this study publishes no supplier ranking.", "method": "country is the recalling firm's location, not the country of manufacture or distribution. Dates arrive as YYYYMMDD strings and are converted to ISO before any comparison. No retry: a failed page aborts the run.", "counts": { "records": 264, "reportedTotal": 264, "distinctFirms": 46, "firmsWithMoreThanOneRecall": 23, "recallsFromThoseFirms": 241, "byClassification": { "Class II": 230, "Class I": 32, "Class III": 1, "Not Yet Classified": 1 }, "byStatus": { "Ongoing": 219, "Terminated": 43, "Completed": 2 }, "byVoluntaryMandated": { "Voluntary: Firm initiated": 239, "FDA Mandated": 25 }, "byInitialFirmNotification": { "Letter": 125, "E-Mail": 119, "Press Release": 7, "": 4, "Telephone": 3, "N/A": 2, "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit": 2, "Other": 1, "Visit": 1 }, "byInitiationYear": { "2012": 2, "2013": 4, "2015": 1, "2016": 5, "2017": 16, "2018": 13, "2019": 3, "2020": 22, "2021": 14, "2022": 12, "2023": 5, "2024": 114, "2025": 52, "2026": 1 } }, "records": [ { "recallNumber": "Z-2124-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2063-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2062-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1979-2025", "eventId": "96896", "firm": "Guangzhou Pluslife Biotech Co., Ltd.", "city": "Guangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-24", "centerClassified": "2025-06-13", "reported": "2025-06-25", "reason": "Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA)." }, { "recallNumber": "Z-0555-2025", "eventId": "95831", "firm": "WINGDERM ELECTRO-OPTICS LTD.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2024-08-23", "centerClassified": "2024-12-05", "reported": "2024-12-11", "reason": "Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)" }, { "recallNumber": "Z-2074-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2115-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1240-2025", "eventId": "96311", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-31", "centerClassified": "2025-02-27", "reported": "2025-03-05", "reason": "For certain MR systems, a scan can be resumed following a Power Monitor trip when the \"6-minute average SAR\" is above the limit indicated on the \"SAR Display\". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant." }, { "recallNumber": "Z-2104-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1625-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2044-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2029-2025", "eventId": "96992", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-05-16", "centerClassified": "2025-06-26", "reported": "2025-07-02", "reason": "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation." }, { "recallNumber": "Z-0323-2023", "eventId": "91137", "firm": "DEWEI MEDICAL EQUIPMENT CO LTD", "city": "Foshan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Other", "initiated": "2022-08-09", "centerClassified": "2022-12-07", "reported": "2022-12-14", "reason": "Products were distributed in the United States without FDA authorization or clearance." }, { "recallNumber": "Z-2096-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2954-2018", "eventId": "80693", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-07-24", "centerClassified": "2018-08-30", "reported": "2018-09-05", "reason": "On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia." }, { "recallNumber": "Z-1632-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2071-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0868-2021", "eventId": "86702", "firm": "Laerdal Medical (Suzhou) Co., Ltd.", "city": "Suzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2020-12-18", "centerClassified": "2021-01-15", "reported": "2021-01-27", "reason": "Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user." }, { "recallNumber": "Z-1493-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-1262-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-0603-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-1003-2026", "eventId": "98238", "firm": "Philips Healthcare (Suzhou) Co., Ltd.", "city": "Suzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "", "initiated": "2025-12-03", "centerClassified": "2026-01-08", "reported": "2026-01-14", "reason": "Potential for incomplete scan due to unstable connection inside of floating sensor." }, { "recallNumber": "Z-0246-2022", "eventId": "89050", "firm": "MAX LUX CORP", "city": "Yangjiangyangjiang", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2021-10-26", "centerClassified": "2021-11-29", "reported": "2021-12-08", "reason": "Excessive ultraviolet-C radiation" }, { "recallNumber": "Z-0602-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-0607-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-2068-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1061-2026", "eventId": "98147", "firm": "HANGZHOU BEVER MEDICAL DEVICES CO., LTD.", "city": "Hangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-29", "centerClassified": "2026-01-12", "reported": "2026-01-21", "reason": "Labeling error, Incorrect expiration date" }, { "recallNumber": "Z-0963-2019", "eventId": "81973", "firm": "BrosMed Medical Co.,Ltd.", "city": "Dongguan", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-12-14", "centerClassified": "2019-02-27", "reported": "2019-03-06", "reason": "Incorrect (higher) Rated Burst Pressure information printed on label." }, { "recallNumber": "Z-2463-2025", "eventId": "97333", "firm": "Zhejiang Luyao Electronics Technology Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2025-01-17", "centerClassified": "2025-08-28", "reported": "2025-09-03", "reason": "Regulatory documentation error and misleading color packaging claim." }, { "recallNumber": "Z-2819-2020", "eventId": "85453", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2020-03-26", "centerClassified": "2020-08-18", "reported": "2020-08-26", "reason": "In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan." }, { "recallNumber": "Z-0208-2022", "eventId": "88757", "firm": "Zhejiang Kindly Medical Devices Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-24", "centerClassified": "2021-11-05", "reported": "2021-11-17", "reason": "Potential for difficulty in safety mechanism activation." }, { "recallNumber": "Z-0600-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-1263-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-2075-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-3307-2024", "eventId": "95288", "firm": "FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD", "city": "Shenzhen", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-06-26", "centerClassified": "2024-09-27", "reported": "2024-10-09", "reason": "The \"DVOT brand\" rapid test kits have not obtained the necessary authorization to be sold in the United States." }, { "recallNumber": "Z-2060-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1636-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2120-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2121-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2083-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0553-2024", "eventId": "93479", "firm": "GE Hangwei Medical Systems, Co. LTD", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2023-11-07", "centerClassified": "2023-12-14", "reported": "2023-12-20", "reason": "GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly." }, { "recallNumber": "Z-2103-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2122-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2094-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2125-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2128-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2080-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2111-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2126-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1491-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-0556-2025", "eventId": "95831", "firm": "WINGDERM ELECTRO-OPTICS LTD.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2024-08-23", "centerClassified": "2024-12-05", "reported": "2024-12-11", "reason": "All model WLA-01 systems sold to US customers are found to have labeling non-compliances" }, { "recallNumber": "Z-3079-2017", "eventId": "77633", "firm": "Master & Frank (Pinghu) Co., Ltd.", "city": "Hangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2017-06-01", "centerClassified": "2017-08-28", "reported": "2017-09-06", "reason": "The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam." }, { "recallNumber": "Z-2704-2020", "eventId": "85868", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-06-20", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge." }, { "recallNumber": "Z-1877-2018", "eventId": "79911", "firm": "Micro-Tech (Nanjing) Co., Ltd.", "city": "Nanjing", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2018-03-12", "centerClassified": "2018-05-15", "reported": "2018-05-23", "reason": "The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury." }, { "recallNumber": "Z-3044-2017", "eventId": "77608", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-05-19", "centerClassified": "2017-08-28", "reported": "2017-09-06", "reason": "Software defect" }, { "recallNumber": "Z-1976-2025", "eventId": "96904", "firm": "HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.", "city": "Hangzhou", "classification": "Class III", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2025-04-25", "centerClassified": "2025-06-13", "reported": "2025-06-25", "reason": "Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as \"Developed by AcoSound,\" Correct should be \"Manufactured by Hangzhou AcoSound.\" And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer \"Blaid\" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements." }, { "recallNumber": "Z-0875-2017", "eventId": "75383", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2016-08-31", "centerClassified": "2016-12-23", "reported": "2017-01-04", "reason": "The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume." }, { "recallNumber": "Z-2046-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2182-2025", "eventId": "97139", "firm": "Flexicare Medical (Dongguan) Ltd.", "city": "Dongguan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-07-11", "centerClassified": "2025-08-01", "reported": "2025-08-13", "reason": "Laryngoscope handles may not illuminate as intended." }, { "recallNumber": "Z-2594-2021", "eventId": "88521", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-02", "centerClassified": "2021-09-29", "reported": "2021-10-06", "reason": "The EXAM acquisition workflow could occasionally freeze after canceling the PET scan." }, { "recallNumber": "Z-2097-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1630-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2056-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2788-2018", "eventId": "80443", "firm": "Guangzhou Wondfo Biotech Co., Ltd.", "city": "GuangZhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-05-18", "centerClassified": "2018-08-11", "reported": "2018-08-22", "reason": "GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard." }, { "recallNumber": "Z-1619-2021", "eventId": "87737", "firm": "LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD", "city": "Beijing", "classification": "Class I", "status": "Completed", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2021-04-26", "centerClassified": "2021-05-28", "reported": "2021-06-09", "reason": "Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S." }, { "recallNumber": "Z-2084-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1239-2025", "eventId": "96311", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-31", "centerClassified": "2025-02-27", "reported": "2025-03-05", "reason": "For certain MR systems, a scan can be resumed following a Power Monitor trip when the \"6-minute average SAR\" is above the limit indicated on the \"SAR Display\". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant." }, { "recallNumber": "Z-2184-2025", "eventId": "97139", "firm": "Flexicare Medical (Dongguan) Ltd.", "city": "Dongguan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-07-11", "centerClassified": "2025-08-01", "reported": "2025-08-13", "reason": "Laryngoscope handles may not illuminate as intended." }, { "recallNumber": "Z-2085-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2187-2025", "eventId": "97139", "firm": "Flexicare Medical (Dongguan) Ltd.", "city": "Dongguan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-07-11", "centerClassified": "2025-08-01", "reported": "2025-08-13", "reason": "Laryngoscope handles may not illuminate as intended." }, { "recallNumber": "Z-2095-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0609-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-0207-2022", "eventId": "88757", "firm": "Zhejiang Kindly Medical Devices Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-24", "centerClassified": "2021-11-05", "reported": "2021-11-17", "reason": "Potential for difficulty in safety mechanism activation." }, { "recallNumber": "Z-0913-2026", "eventId": "98064", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Telephone", "initiated": "2025-11-14", "centerClassified": "2025-12-18", "reported": "2025-12-24", "reason": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings." }, { "recallNumber": "Z-0604-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-0448-2021", "eventId": "86269", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-08-05", "centerClassified": "2020-11-12", "reported": "2020-11-18", "reason": "A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation." }, { "recallNumber": "Z-2098-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1488-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-2733-2024", "eventId": "95222", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-07-12", "centerClassified": "2024-08-26", "reported": "2024-09-04", "reason": "The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install." }, { "recallNumber": "Z-1265-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-2057-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0612-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-2043-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2306-2026", "eventId": "98917", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "", "initiated": "2026-04-21", "centerClassified": "2026-06-03", "reported": "2026-06-10", "reason": "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making." }, { "recallNumber": "Z-1242-2025", "eventId": "96311", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-31", "centerClassified": "2025-02-27", "reported": "2025-03-05", "reason": "For certain MR systems, a scan can be resumed following a Power Monitor trip when the \"6-minute average SAR\" is above the limit indicated on the \"SAR Display\". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant." }, { "recallNumber": "Z-1627-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-1495-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-0614-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-1629-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2093-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2088-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2051-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2053-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2185-2025", "eventId": "97139", "firm": "Flexicare Medical (Dongguan) Ltd.", "city": "Dongguan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-07-11", "centerClassified": "2025-08-01", "reported": "2025-08-13", "reason": "Laryngoscope handles may not illuminate as intended." }, { "recallNumber": "Z-2100-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2064-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1884-2018", "eventId": "78975", "firm": "SANTA JOY ORNAMENT & GIFTWARE CO", "city": "Dongguan City", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-11-21", "centerClassified": "2018-06-01", "reported": "2018-06-13", "reason": "It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products." }, { "recallNumber": "Z-0447-2021", "eventId": "86269", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-08-05", "centerClassified": "2020-11-12", "reported": "2020-11-18", "reason": "A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation." }, { "recallNumber": "Z-2045-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2067-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2052-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0773-2019", "eventId": "81920", "firm": "NEUSOFT MEDICAL SYSTEMS IMP & EX", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2019-01-09", "centerClassified": "2019-02-05", "reported": "2019-02-13", "reason": "For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons." }, { "recallNumber": "Z-1300-2022", "eventId": "90421", "firm": "CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.", "city": "Changzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "", "initiated": "2022-06-02", "centerClassified": "2022-06-28", "reported": "2022-07-06", "reason": "One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates" }, { "recallNumber": "Z-0466-2013", "eventId": "63553", "firm": "Philips And Neusoft Medical Systems Co., Ltd.", "city": "Shenyang, Liaoning", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2012-10-18", "centerClassified": "2012-12-04", "reported": "2012-12-12", "reason": "The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners." }, { "recallNumber": "Z-0606-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-1633-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2082-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1353-2023", "eventId": "91870", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2023-03-01", "centerClassified": "2023-04-07", "reported": "2023-04-19", "reason": "Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images." }, { "recallNumber": "Z-2656-2023", "eventId": "93054", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2023-09-08", "centerClassified": "2023-09-29", "reported": "2023-10-11", "reason": "There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days." }, { "recallNumber": "Z-2092-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2110-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0183-2024", "eventId": "93146", "firm": "Carl Zeiss Suzhou Co., Ltd.", "city": "Suzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2023-08-18", "centerClassified": "2023-10-26", "reported": "2023-11-01", "reason": "Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components." }, { "recallNumber": "Z-3306-2024", "eventId": "95288", "firm": "FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD", "city": "Shenzhen", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-06-26", "centerClassified": "2024-09-27", "reported": "2024-10-09", "reason": "The \"DVOT brand\" rapid test kits have not obtained the necessary authorization to be sold in the United States." }, { "recallNumber": "Z-1626-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-0550-2025", "eventId": "95674", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-10-24", "centerClassified": "2024-11-25", "reported": "2024-12-04", "reason": "Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List." }, { "recallNumber": "Z-2049-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2077-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1492-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-2114-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2073-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-3308-2024", "eventId": "95288", "firm": "FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD", "city": "Shenzhen", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-06-26", "centerClassified": "2024-09-27", "reported": "2024-10-09", "reason": "The \"DVOT brand\" rapid test kits have not obtained the necessary authorization to be sold in the United States." }, { "recallNumber": "Z-2712-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-2799-2020", "eventId": "85948", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-07-16", "centerClassified": "2020-08-13", "reported": "2020-08-19", "reason": "1)\t1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions." }, { "recallNumber": "Z-0605-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-0446-2021", "eventId": "86269", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-08-05", "centerClassified": "2020-11-12", "reported": "2020-11-18", "reason": "A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation." }, { "recallNumber": "Z-2521-2020", "eventId": "85196", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-02-27", "centerClassified": "2020-07-06", "reported": "2020-07-15", "reason": "Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation." }, { "recallNumber": "Z-1257-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-2117-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2105-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0611-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-2050-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2058-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0608-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-2116-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2065-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2102-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0445-2021", "eventId": "86269", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-08-05", "centerClassified": "2020-11-12", "reported": "2020-11-18", "reason": "A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation." }, { "recallNumber": "Z-0209-2022", "eventId": "88757", "firm": "Zhejiang Kindly Medical Devices Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-24", "centerClassified": "2021-11-05", "reported": "2021-11-17", "reason": "Potential for difficulty in safety mechanism activation." }, { "recallNumber": "Z-1165-2013", "eventId": "64783", "firm": "Philips And Neusoft Medical Systems Co., Ltd.", "city": "Shenyang, Liaoning", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2013-03-04", "centerClassified": "2013-04-23", "reported": "2013-05-01", "reason": "User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel." }, { "recallNumber": "Z-2083-2012", "eventId": "62481", "firm": "Philips And Neusoft Medical Systems Co., Ltd.", "city": "Shenyang, Liaoning", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2012-06-08", "centerClassified": "2012-07-26", "reported": "2012-08-01", "reason": "One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach." }, { "recallNumber": "Z-0206-2022", "eventId": "88757", "firm": "Zhejiang Kindly Medical Devices Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-24", "centerClassified": "2021-11-05", "reported": "2021-11-17", "reason": "Potential for difficulty in safety mechanism activation." }, { "recallNumber": "Z-2118-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2107-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0640-2024", "eventId": "93574", "firm": "Philips Healthcare (Suzhou) Co., Ltd.", "city": "Suzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2022-12-23", "centerClassified": "2024-01-05", "reported": "2024-01-17", "reason": "Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operator\u0019s voice are too quiet, patient can\u0019t hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP." }, { "recallNumber": "Z-0601-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-0610-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-2703-2020", "eventId": "85868", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-06-20", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge." }, { "recallNumber": "Z-2789-2018", "eventId": "80443", "firm": "Guangzhou Wondfo Biotech Co., Ltd.", "city": "GuangZhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-05-18", "centerClassified": "2018-08-11", "reported": "2018-08-22", "reason": "GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard." }, { "recallNumber": "Z-0205-2022", "eventId": "88757", "firm": "Zhejiang Kindly Medical Devices Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-24", "centerClassified": "2021-11-05", "reported": "2021-11-17", "reason": "Potential for difficulty in safety mechanism activation." }, { "recallNumber": "Z-0552-2024", "eventId": "93479", "firm": "GE Hangwei Medical Systems, Co. LTD", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2023-11-07", "centerClassified": "2023-12-14", "reported": "2023-12-20", "reason": "GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly." }, { "recallNumber": "Z-1978-2025", "eventId": "96896", "firm": "Guangzhou Pluslife Biotech Co., Ltd.", "city": "Guangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-24", "centerClassified": "2025-06-13", "reported": "2025-06-25", "reason": "Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA)." }, { "recallNumber": "Z-0888-2026", "eventId": "98118", "firm": "SHENZHEN ATOMSTACK TECHNOLOGIES", "city": "Guangdong", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "N/A", "initiated": "2025-09-30", "centerClassified": "2025-12-31", "reported": "2026-01-07", "reason": "Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)" }, { "recallNumber": "Z-1233-2025", "eventId": "96193", "firm": "BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.", "city": "Suzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-10", "centerClassified": "2025-02-25", "reported": "2025-03-05", "reason": "Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade." }, { "recallNumber": "Z-2119-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0616-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-2787-2018", "eventId": "80443", "firm": "Guangzhou Wondfo Biotech Co., Ltd.", "city": "GuangZhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-05-18", "centerClassified": "2018-08-11", "reported": "2018-08-22", "reason": "GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard." }, { "recallNumber": "Z-0768-2025", "eventId": "96035", "firm": "Jinan Bodor Cnc Machine Co Ltd", "city": "Jinan", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2024-12-19", "centerClassified": "2025-01-18", "reported": "2025-01-29", "reason": "Non-compliant laser products" }, { "recallNumber": "Z-2061-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1620-2021", "eventId": "87737", "firm": "LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD", "city": "Beijing", "classification": "Class I", "status": "Completed", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2021-04-26", "centerClassified": "2021-05-28", "reported": "2021-06-09", "reason": "Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S." }, { "recallNumber": "Z-2089-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1573-2016", "eventId": "73741", "firm": "Philips and Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2016-03-24", "centerClassified": "2016-04-27", "reported": "2016-05-04", "reason": "The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be" }, { "recallNumber": "Z-1638-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2113-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1878-2018", "eventId": "79911", "firm": "Micro-Tech (Nanjing) Co., Ltd.", "city": "Nanjing", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2018-03-12", "centerClassified": "2018-05-15", "reported": "2018-05-23", "reason": "The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury." }, { "recallNumber": "Z-1628-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2091-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0087-2023", "eventId": "90888", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2022-05-30", "centerClassified": "2022-10-13", "reported": "2022-10-19", "reason": "The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient." }, { "recallNumber": "Z-1217-2019", "eventId": "80547", "firm": "Guangzhou Improve Medical Instruments Co., Ltd.", "city": "Guangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2017-09-22", "centerClassified": "2019-04-24", "reported": "2019-05-01", "reason": "Complain due to the hub needle came out when the nurse draw the blood and removed the tube." }, { "recallNumber": "Z-1261-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-2183-2025", "eventId": "97139", "firm": "Flexicare Medical (Dongguan) Ltd.", "city": "Dongguan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-07-11", "centerClassified": "2025-08-01", "reported": "2025-08-13", "reason": "Laryngoscope handles may not illuminate as intended." }, { "recallNumber": "Z-0914-2026", "eventId": "98064", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Telephone", "initiated": "2025-11-14", "centerClassified": "2025-12-18", "reported": "2025-12-24", "reason": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings." }, { "recallNumber": "Z-2106-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1160-2021", "eventId": "87289", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2021-01-25", "centerClassified": "2021-03-02", "reported": "2021-03-10", "reason": "There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient." }, { "recallNumber": "Z-0795-2025", "eventId": "95818", "firm": "JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD", "city": "Danyang", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-12-09", "centerClassified": "2025-01-03", "reported": "2025-01-15", "reason": "Oxygen concentrator may melt or catch on fire during use." }, { "recallNumber": "Z-1075-2022", "eventId": "90104", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2019-07-30", "centerClassified": "2022-05-12", "reported": "2022-05-18", "reason": "X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure." }, { "recallNumber": "Z-2790-2018", "eventId": "80519", "firm": "Guangzhou Improve Medical Instruments Co., Ltd.", "city": "Guangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2016-10-19", "centerClassified": "2018-08-11", "reported": "2018-08-22", "reason": "Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip." }, { "recallNumber": "Z-1187-2016", "eventId": "73438", "firm": "Covidien Medical Products (Shanghai) Manufacturing L.L.C.", "city": "Shanghaishi", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2016-02-23", "centerClassified": "2016-03-17", "reported": "2016-03-23", "reason": "Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint\" Percutaneous Antenna with Thermosphere\" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint\" Percutaneous Antenna." }, { "recallNumber": "Z-2048-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2081-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2955-2018", "eventId": "80693", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-07-24", "centerClassified": "2018-08-30", "reported": "2018-09-05", "reason": "On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia." }, { "recallNumber": "Z-2522-2020", "eventId": "85804", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-05-08", "centerClassified": "2020-07-06", "reported": "2020-07-15", "reason": "Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media." }, { "recallNumber": "Z-2072-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2713-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-2127-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1279-2019", "eventId": "82753", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2018-10-22", "centerClassified": "2019-05-21", "reported": "2019-05-29", "reason": "Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss." }, { "recallNumber": "Z-1507-2022", "eventId": "90224", "firm": "Guangdong Haiou Medical Apparatus Co., Ltd", "city": "Puning", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "initiated": "2022-06-10", "centerClassified": "2022-08-05", "reported": "2022-08-17", "reason": "Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user" }, { "recallNumber": "Z-2042-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2090-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1631-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2956-2018", "eventId": "80693", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-07-24", "centerClassified": "2018-08-30", "reported": "2018-09-05", "reason": "On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia." }, { "recallNumber": "Z-1258-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-1490-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-2641-2020", "eventId": "85771", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2020-05-23", "centerClassified": "2020-07-17", "reported": "2020-07-29", "reason": "Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium." }, { "recallNumber": "Z-0615-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-1635-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-1264-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-1166-2013", "eventId": "64783", "firm": "Philips And Neusoft Medical Systems Co., Ltd.", "city": "Shenyang, Liaoning", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2013-03-04", "centerClassified": "2013-04-23", "reported": "2013-05-01", "reason": "User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel." }, { "recallNumber": "", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Not Yet Classified", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": null, "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0876-2017", "eventId": "75383", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2016-08-31", "centerClassified": "2016-12-23", "reported": "2017-01-04", "reason": "The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume." }, { "recallNumber": "Z-2149-2025", "eventId": "97284", "firm": "Jinan Bodor Cnc Machine Co Ltd", "city": "Jinan", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "N/A", "initiated": "2025-02-07", "centerClassified": "2025-07-23", "reported": "2025-07-30", "reason": "The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2)." }, { "recallNumber": "Z-1267-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-0945-2022", "eventId": "89755", "firm": "Acon Biotech (Hangzhou) Co., Ltd.", "city": "Hangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2022-01-09", "centerClassified": "2022-04-15", "reported": "2022-04-27", "reason": "Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results." }, { "recallNumber": "Z-2099-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1650-2016", "eventId": "73832", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2015-05-02", "centerClassified": "2016-05-11", "reported": "2016-05-18", "reason": "It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to \"Right\" in the system setting - scanner options." }, { "recallNumber": "Z-1398-2022", "eventId": "90602", "firm": "Haimen Shengbang Laboratory Equipment Co. Ltd.", "city": "Nantong", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2022-07-12", "centerClassified": "2022-08-08", "reported": "2022-08-17", "reason": "Distributed VTM outside of VTM Guidance and without clearance." }, { "recallNumber": "Z-0580-2018", "eventId": "78469", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2017-10-11", "centerClassified": "2018-02-09", "reported": "2018-02-21", "reason": "Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems." }, { "recallNumber": "Z-2708-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-2069-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2066-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1400-2022", "eventId": "90602", "firm": "Haimen Shengbang Laboratory Equipment Co. Ltd.", "city": "Nantong", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2022-07-12", "centerClassified": "2022-08-08", "reported": "2022-08-17", "reason": "Distributed VTM outside of VTM Guidance and without clearance." }, { "recallNumber": "Z-2112-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1281-2019", "eventId": "82753", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2018-10-22", "centerClassified": "2019-05-21", "reported": "2019-05-29", "reason": "Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss." }, { "recallNumber": "Z-2101-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2186-2025", "eventId": "97139", "firm": "Flexicare Medical (Dongguan) Ltd.", "city": "Dongguan", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-07-11", "centerClassified": "2025-08-01", "reported": "2025-08-13", "reason": "Laryngoscope handles may not illuminate as intended." }, { "recallNumber": "Z-2078-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2714-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-1273-2021", "eventId": "87473", "firm": "Philips Healthcare (Suzhou) Co., Ltd.", "city": "Suzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-02-24", "centerClassified": "2021-03-17", "reported": "2021-03-24", "reason": "Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position." }, { "recallNumber": "Z-0066-2014", "eventId": "66341", "firm": "GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD", "city": "Beijing", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2013-09-18", "centerClassified": "2013-10-24", "reported": "2013-10-30", "reason": "GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality." }, { "recallNumber": "Z-1145-2014", "eventId": "67520", "firm": "China Daheng Group Inc.", "city": "Beijing", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Visit", "initiated": "2013-07-15", "centerClassified": "2014-03-14", "reported": "2014-03-26", "reason": "Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers" }, { "recallNumber": "Z-2109-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2709-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-2593-2021", "eventId": "88521", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-02", "centerClassified": "2021-09-29", "reported": "2021-10-06", "reason": "The EXAM acquisition workflow could occasionally freeze after canceling the PET scan." }, { "recallNumber": "Z-1708-2020", "eventId": "85340", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2019-08-26", "centerClassified": "2020-04-15", "reported": "2020-04-22", "reason": "Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose." }, { "recallNumber": "Z-2059-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2070-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2549-2018", "eventId": "80524", "firm": "Guangzhou Improve Medical Instruments Co., Ltd.", "city": "Guangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2017-09-22", "centerClassified": "2018-07-26", "reported": "2018-08-01", "reason": "Leaks complaints." }, { "recallNumber": "Z-3045-2017", "eventId": "77608", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-05-19", "centerClassified": "2017-08-28", "reported": "2017-09-06", "reason": "Software defect" }, { "recallNumber": "Z-2472-2020", "eventId": "85809", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-05-08", "centerClassified": "2020-06-30", "reported": "2020-07-08", "reason": "Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium." }, { "recallNumber": "Z-1259-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-0613-2025", "eventId": "95704", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2024-11-05", "centerClassified": "2024-12-04", "reported": "2024-12-11", "reason": "GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur." }, { "recallNumber": "Z-1243-2025", "eventId": "96311", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-31", "centerClassified": "2025-02-27", "reported": "2025-03-05", "reason": "For certain MR systems, a scan can be resumed following a Power Monitor trip when the \"6-minute average SAR\" is above the limit indicated on the \"SAR Display\". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant." }, { "recallNumber": "Z-2055-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1624-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2123-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1788-2021", "eventId": "87752", "firm": "Getinge (Suzhou) Co Ltd", "city": "Suzhou City", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "", "initiated": "2021-04-15", "centerClassified": "2021-06-03", "reported": "2021-06-09", "reason": "There is a potential for abnormal inflation of the mattress." }, { "recallNumber": "Z-2079-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-0237-2019", "eventId": "81176", "firm": "Micro-Tech (Nanjing) Co., Ltd.", "city": "Nanjing", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2018-09-20", "centerClassified": "2018-10-23", "reported": "2018-10-31", "reason": "Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units" }, { "recallNumber": "Z-1290-2023", "eventId": "91969", "firm": "GAGA PRO LIGHTING EQUIPMENT CO.,", "city": "Guangzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2022-09-23", "centerClassified": "2023-03-29", "reported": "2023-04-05", "reason": "GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products." }, { "recallNumber": "Z-2800-2020", "eventId": "85948", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-07-16", "centerClassified": "2020-08-13", "reported": "2020-08-19", "reason": "1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036)" }, { "recallNumber": "Z-1241-2025", "eventId": "96311", "firm": "GE Healthcare (China) Co., Ltd.", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-01-31", "centerClassified": "2025-02-27", "reported": "2025-03-05", "reason": "For certain MR systems, a scan can be resumed following a Power Monitor trip when the \"6-minute average SAR\" is above the limit indicated on the \"SAR Display\". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant." }, { "recallNumber": "Z-2705-2020", "eventId": "85868", "firm": "Shanghai United Imaging Healthcare Co., Ltd.", "city": "Shanghai", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2020-06-20", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge." }, { "recallNumber": "Z-1494-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-2711-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-0001-2023", "eventId": "90773", "firm": "Jiangsu Well Biotech Co.,Ltd.", "city": "Changzhou", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2022-08-09", "centerClassified": "2022-10-07", "reported": "2022-10-19", "reason": "Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance." }, { "recallNumber": "Z-0915-2026", "eventId": "98064", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Telephone", "initiated": "2025-11-14", "centerClassified": "2025-12-18", "reported": "2025-12-24", "reason": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings." }, { "recallNumber": "Z-1637-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-1399-2022", "eventId": "90602", "firm": "Haimen Shengbang Laboratory Equipment Co. Ltd.", "city": "Nantong", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2022-07-12", "centerClassified": "2022-08-08", "reported": "2022-08-17", "reason": "Distributed VTM outside of VTM Guidance and without clearance." }, { "recallNumber": "Z-2076-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2086-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2710-2020", "eventId": "85923", "firm": "Chengdu Ai Qin E-commerce Co., Ltd", "city": "Gao Xin", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Press Release", "initiated": "2020-06-23", "centerClassified": "2020-07-27", "reported": "2020-08-05", "reason": "Colored contact lenses were distributed without FDA clearance." }, { "recallNumber": "Z-1280-2019", "eventId": "82753", "firm": "Neusoft Medical Systems Co., Ltd.", "city": "Shenyang", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2018-10-22", "centerClassified": "2019-05-21", "reported": "2019-05-29", "reason": "Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss." }, { "recallNumber": "Z-0204-2022", "eventId": "88757", "firm": "Zhejiang Kindly Medical Devices Co., Ltd.", "city": "Wenzhou", "classification": "Class II", "status": "Terminated", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2021-08-24", "centerClassified": "2021-11-05", "reported": "2021-11-17", "reason": "Potential for difficulty in safety mechanism activation." }, { "recallNumber": "Z-2047-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1764-2025", "eventId": "96046", "firm": "Contec Medical Systems Co., Ltd.", "city": "Qinhuangdao", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-04-10", "centerClassified": "2025-05-14", "reported": "2025-05-21", "reason": "Patient monitor has nine identified cybersecurity vulnerabilities." }, { "recallNumber": "Z-2108-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-2054-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1506-2022", "eventId": "90224", "firm": "Guangdong Haiou Medical Apparatus Co., Ltd", "city": "Puning", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "initiated": "2022-06-10", "centerClassified": "2022-08-05", "reported": "2022-08-17", "reason": "Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user" }, { "recallNumber": "Z-2087-2024", "eventId": "94520", "firm": "Jiangsu Shenli Medical Production Co., Ltd.", "city": "Changzhou", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "E-Mail", "initiated": "2024-04-05", "centerClassified": "2024-06-10", "reported": "2024-05-29", "reason": "Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k)." }, { "recallNumber": "Z-1634-2025", "eventId": "96634", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class I", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-03-21", "centerClassified": "2025-04-29", "reported": "2025-05-07", "reason": "Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation." }, { "recallNumber": "Z-2030-2025", "eventId": "96992", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-05-16", "centerClassified": "2025-06-26", "reported": "2025-07-02", "reason": "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation." }, { "recallNumber": "Z-1260-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." }, { "recallNumber": "Z-1489-2018", "eventId": "79697", "firm": "Beijing Syntech Laser Co., Ltd", "city": "Beijing", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "FDA Mandated", "initialFirmNotification": "Letter", "initiated": "2017-07-03", "centerClassified": "2018-05-02", "reported": "2018-05-09", "reason": "The noncompliance is that the certification label was not affixed on the product, with statement \"Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007\"." }, { "recallNumber": "Z-0579-2018", "eventId": "78469", "firm": "GE Medical Systems China Co., Ltd.", "city": "Wuxi", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2017-10-11", "centerClassified": "2018-02-09", "reported": "2018-02-21", "reason": "Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems." }, { "recallNumber": "Z-1266-2026", "eventId": "97801", "firm": "Changchun Wancheng Bio-Electron Co., Ltd.", "city": "Changchun", "classification": "Class II", "status": "Ongoing", "voluntaryMandated": "Voluntary: Firm initiated", "initialFirmNotification": "Letter", "initiated": "2025-11-22", "centerClassified": "2026-02-04", "reported": "2026-02-11", "reason": "Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention." } ] }