PHILIPS BATTERY — Class II medical device recall Z-1137-2021
Ongoing recall by Respironics California, LLC, reported 2021-03-03, distributed nationwide. Due to unqualified "design verification" batteries being shipped to customers.
| Recall number | Z-1137-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respironics California, LLC, Carlsbad, CA, United States |
| Recall initiated | 2021-01-06 |
| Classified | 2021-02-19 |
| Reported by FDA | 2021-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 94 batteries |
| Lot numbers | M94663-P1 |
| Model numbers | 1076374 |
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 for recall
Due to unqualified "design verification" batteries being shipped to customers.
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-1137-2021. 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.