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Recall Observatory FDA recall evidence

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

January 06, 2021

Class II

Product summary

Firm
Respironics California, LLC
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

    reason.no_named_rule · v1.0.0

    Due to unqualified "design verification" batteries being shipped to customers.