Respironics California, LLC recalls PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is int…

Recall date

January 6, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1137-2021

FDA classification

Class II

Brand / firm

Respironics California, LLC

Sold / distributed

U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.