Recall Z-0914-2026 ยท BSZ Gas-Machine, Anesthesia
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
| Date | Dec 18, 2025 (initiated Nov 14, 2025) |
| Status | Open, Classified |
| 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 oc |
| Root cause | Component change control |
| Action | GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 11/14/2025 via letter using a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by Customer/User: "Pending correction by GE HealthCare, you can continue to use the Anesthesia machine with affected power management boards by following the instructions below: 1. Always ensure the device has a secure connection to an AC mains power source. 2. If there is a loss of AC mains power to the system leading to an unexpected system shutdown: - Promptly i |
| Quantity | 888 units |
| Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Argentina, Australia, Bahamas, Bangladesh, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Canada, China, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, H |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213867 | Carestation 750/750c Datex-Ohmeda, Inc., Mar 28, 2023 |