FDA recall Z-1137-2021

Respironics California, LLC · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2021-01-06
Report date
2021-03-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2021