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FDAJanuary 6, 2021device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

respironics californiarespironics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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