GE Healthcare CARESTATION 620 A2 — Class I medical device recall Z-1625-2025
Ongoing recall by GE Medical Systems China Co., Ltd., reported 2025-05-07, distributed nationwide. Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilati
| Recall number | Z-1625-2025 |
|---|---|
| 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 | 2025-03-21 |
| Classified | 2025-04-29 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 1,483 units |
| UPC / GTIN / UDI-DI | 00840682124546 |
| Serial numbers | SM623010001WB, SM623010002WB, SM623010003WB, SM623010004WB, SM623010005WB, SM623010006WB, SM623020001WB, SM623020002WB, SM623050001WB, SM623050002WB, SM623050003WB, SM623050004WB, SM623050005WB, SM623060001WB, SM623060002WB, SM623060003WB, SM623060004WB, SM623060006WB, SM623060007WB, SM623060008WB, SM623060009WB, SM623060010WB, SM623060011WB, SM623070005WB, SM623080001WB and 475 more |
| Model numbers | 1012-9620-002 |
Product
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Reason for recall
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.
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-1625-2025. 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.