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FDAFDA · Food and drugs·Recall number Z-0908-2022

Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)

Published April 27, 2022 · Recall initiated: February 28, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Respironics California, LLC
Distributor
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, Albania, Algeria, American Samoa, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Comoros, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland , Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, St. Pier, Miquel., Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Kingdom, Utd. Arab. Emir., Venezuela, Vietnam, Wallis, Futuna, Zambia, Japan.
Lot
All Lots & Serial Numbers
Risk classification
Class I
Area (FDA)
device
Country
United States

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