Medical device recalls Moderate risk

Respironics California, LLC recalls Philips Respironics V680 Ventilator Part Number 850011 - 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-0901-2021
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 V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

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