GE Healthcare Aisys CS2 Anesthesia System — Class I medical device recall Z-1389-2022
Terminated recall by GE Healthcare, LLC, reported 2022-07-27, distributed nationwide. There is a potential reversal of the O2 and air cylinder pressure transducer connections.
| Recall number | Z-1389-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-06-01 |
| Classified | 2022-07-19 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BO, BR, CA, CH, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IN, IS, IT, JP, KE, KR, KW, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, UY, ZA |
| Quantity | 5,372 devices |
| UPC / GTIN / UDI-DI | 00840682102292, 00840682102322 |
| Serial numbers | 00506, 02331, 02336, 02337, 02510, APKZ00247 |
| Model numbers | 1009-9050-000, 1011-9050-000 |
Product
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Reason for recall
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
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-1389-2022. 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.