Recall Atlas

GE Medical Systems China recalls

5 official recalls and safety alerts involving GE Medical Systems China since 2023-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with GE Medical Systems China or the relevant agency.

  1. 2026-06-10
  2. US
    Drugs & medicalClass II

    GE Medical Systems China Co., Ltd. recalls MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

    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…

    FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide - US Nationwide distribution in the states of Florida and Georgia.…Official notice →
  3. 2025-12-24
  4. US
    Drugs & medicalClass I

    GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;…

    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…

    FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice →
  5. 2025-07-02
  6. US
    Drugs & medicalClass II

    GE Medical Systems China Co., Ltd. recalls GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system

    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…

    FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution.Official notice →
  7. 2025-05-07
  8. US
    Drugs & medicalClass I

    GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.

    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…

    FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria,…Official notice →
  9. 2023-10-11
  10. US
    Drugs & medicalClass II

    GE Medical Systems China Co., Ltd. recalls F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

    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…

    FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →