GE Healthcare Carestation anesthesia system — Class I medical device recall Z-0914-2026
Ongoing recall by GE Medical Systems China Co., Ltd., reported 2025-12-24, distributed nationwide. Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power ma
| Recall number | Z-0914-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems China Co., Ltd., Wuxi, China |
| Recall initiated | 2025-11-14 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BG, BR, BS, CA, CN, CR, CZ, DE, DO, EC, EG, ES, FI, FR, GB, GT, HK, ID, IE, IL, IN, IQ, IT, JP, KR, KW, LK, LT, LV, MA, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TW, UA, VE, VN, ZA |
| Quantity | 888 units |
| UPC / GTIN / UDI-DI | 00840682145596, 00840682146425, 00840682146463, 00840682146470 |
| Model numbers | 1012-9750-000, 1012-9750-002, 1012-9755-000, 1012-9755-002 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0914-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.