GE Healthcare — Class I medical device recall Z-0010-2014
Terminated recall by GE Healthcare, LLC, reported 2013-10-23, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the disp
| Recall number | Z-0010-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-08-28 |
| Classified | 2013-10-15 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2015-01-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BO, BR, CA, CH, CL, CN, CZ, DE, EG, ES, FI, FR, GB, GR, HR, ID, IN, IQ, IT, JP, KR, KW, LB, LT, MA, MX, NG, NL, NZ, PE, PH, PK, PL, SA, SE, TH, TR, TW, VE, VN, ZA |
| Serial numbers | 5297602, 5297658, 5320342, 5321204, 5322929, 5323093, 5323487, 5323856, 5324012, 5324418, 5324492, 5324558, 5324604, 5324655, 5324664, 5324672, 5324727, 5324756, 5324910, 5324911, 5324971, 5325257, 5325311, 5325318, 5325323 and 475 more |
Product
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
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-0010-2014. 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.