FDA Device recall Z-1227-2022
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators
- FDA Device
- Class I
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class I recall of Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators 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-1227-2022 |
| 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
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
Reason
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Identifiers
| code_info | Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1227-2022%22
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