Recall Z-1625-2025 ยท BSZ Gas-Machine, Anesthesia
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
| Date | Apr 29, 2025 (initiated Mar 21, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice on 03/21/2025. The notice explained the safety issue with the device, potential risk, and requested the following actions: The anesthesia system may continue to be used following these instructions: Perform the Ventilation Screening Test specified in Appendix 1 for each affected Carestation system. If the Carestation system passes the Ventilation Screening Test, you can continue to use the device. If the Carestation system fails the Ventilation Screening Test and must be used prior to the system being corrected by GE HealthCare |
| Quantity | 1483 units |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.