Replacement back up batteries distributed on or after April 1 — Class I medical device recall Z-1227-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-06-15, distributed nationwide. Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC m
| Recall number | Z-1227-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-04-18 |
| Classified | 2022-06-06 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BR, CA, CL, CN, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, HU, ID, IE, IN, IT, JP, KE, KR, KW, LV, MX, MY, NG, NI, NL, NO, NZ, PA, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, UY |
| Quantity | 88,379 batteries |
Product
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Reason for recall
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
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-1227-2022. 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.