GE Healthcare — Class II medical device recall Z-0681-2016
Terminated recall by GE Medical Systems, LLC, reported 2016-01-27, distributed nationwide. The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which co
| Recall number | Z-0681-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2015-12-15 |
| Classified | 2016-01-21 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LK, LT, LV, MA, MX, MY, NI, NL, NO, NZ, OM, PE, PH, PK, PL, QA, RO, RS, SA, SE, SG, SK, TH, TR, TW, VE, VN, ZA |
| Quantity | 2,627 |
Product
GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Reason for recall
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
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-0681-2016. 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.