GE Healthcare — Class I medical device recall Z-0009-2014
Terminated recall by GE Healthcare, LLC, reported 2013-10-23, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisy
| Recall number | Z-0009-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-10-15 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2015-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CH, ES, GB, JP, KE, KR, KW, LB, LT, LV, MA, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UY, VE, VN, ZA |
| Serial numbers | ANAN00960, ANAN00961, ANAP00691, ANAP00777, ANAP00778, ANAP00779, ANAP00780, ANAP00781, ANAP00782, ANAP00783, ANAP00784, ANAP00785, ANAP00786, ANAP00787, ANAP00788, ANAP00789, ANAP00790, ANAP00947, ANAP00948, ANAP01159, ANAP01160, ANAP01161, ANAP01162, ANAP01163, ANAP01164 and 475 more |
Product
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
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-0009-2014. 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.