Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinati…

Recall date

October 30, 2020

Source

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

Recall number

Z-0897-2021

FDA classification

Class II

Brand / firm

Respironics California, LLC

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI,…

Why it was recalled

Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.

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 Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.