Respironics California, LLC recalls Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 107670…

Recall date

February 28, 2022

Source

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

Recall number

Z-0907-2022

FDA classification

Class I

Brand / firm

Respironics California, LLC

Sold / distributed

Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Afghanistan,…

Why it was recalled

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)