FDA Device recall Z-1286-2022
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anes…
- FDA Device
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anes… by Ge Healthcare, citing backup batteries can fail earlier than their estimated life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1286-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-25 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Reason
Backup batteries can fail earlier than their estimated life.
Identifiers
| code_info | Field Replacement Units (FRU) Battery kits - PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) or PN: 585678…Field Replacement Units (FRU) Battery kits - PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) or PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR), that may have been installed by the customer into any of the following anesthesia systems: o Avance 1009-9002-000 o Aespire View 1009-9212-000 o Avance CS2 and Avance CS2 Pro 1009-9050-000 |
|---|
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-1286-2022%22
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