FDA Device recall Z-1226-2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carest…
- FDA Device
- Class I
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class I recall of Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carest… by Ge Healthcare, citing insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1226-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-04-18 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Reason
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Identifiers
| code_info | a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX; UDI/DI Number:00840682102346; Serial Numbers: CBRZ06959, CB…a. Model Number: 1506-8600-000 and/or 1506-8600-000-XXXXXX; UDI/DI Number:00840682102346; Serial Numbers: CBRZ06959, CBRZ80171, CBRZ80257, CBRZ40111, CBRZ85239, CBRZ05811, CBRZ05833, CBRZ05850, CBRZ05852, CBRZ05857, CBRA01434, CBRA01435, CBRA01436, CBRZ80137, CBRZ80153, CBRZ80197, CBRZ84891, CBRA01744, CBRA01745, CBRA01746, CBRA01747, CBRA01748, CBRA01751, CBRA01756, CBRZ85298, CBRZ85300, CBRZ85305, CBRZ85338, CBRZ07643, CBRZ07668, CBRZ07678, CBRZ07690, CBRZ07691, CBRZ81955, CBRZ82059, CBRZ85119, CBRA01503, CBRA01506, CBRZ03482, CBRZ03483, CBRZ03492, CBRZ03494, CBRA01674, CBRA01675, CBRA01676, CBRA01677, CBRA01678, CBRA01679, CBRA01680, CBRA01681, CBRA01682, CBRA01683, CBRA01684, CBRA01685, CBRA01686, CBRA01687, CBRA01688, CBRZ07601, CBRZ07612, CBRZ07624, CBRZ07632, CBRZ07638, CBRZ07640, CBRZ07641, CBRZ07652, CBRZ07657, CBRZ07660, CBRZ07666, CBRZ07680, CBRZ07682, CBRZ07686, CBRZ07688, CBRZ07692, CBRZ07693, CBRZ07696, CBRZ85174, CBRZ85187, CBRZ85322, CBRA01742, CBRA01743, CBRA01749, CBR |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1226-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.