Device 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.
Z-1137-2021
Product summary
- Event
- Event 87314
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 94 batteries
- Official record key
device-enforcement:Z-1137-2021
Official wording
Reason: Due to unqualified "design verification" batteries being shipped to customers.
Code information: Battery Model/Part Number: 1076374 Lot Code: M94663-P1
Distribution pattern: U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
Derived failure modes
-
Unknown
Due to unqualified "design verification" batteries being shipped to customers.