FDA-Device2021-03-03Class II
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.
Respironics California, LLC
Hazard
Due to unqualified "design verification" batteries being shipped to customers.
Sold states
U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
Affected count
94 batteries
Manufactured in
2271 Cosmos Ct, N/A, Carlsbad, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2021Don't want to check this manually?
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