FDA Device recall Z-1137-2021
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used onl…
- FDA Device
- Class II
- ongoing
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used onl… by Respironics California, citing due to unqualified "design verification" batteries being shipped to customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1137-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-01-06 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Respironics California |
| Distribution | US |
Product
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Reason
Due to unqualified "design verification" batteries being shipped to customers.
Identifiers
| code_info | Battery Model/Part Number: 1076374 Lot Code: M94663-P1 |
|---|
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-1137-2021%22
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