FDA-Device2022-04-27Class I

Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States

Respironics California, LLC
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.

Sold states
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.
Manufactured in
2271 Cosmos Ct, Carlsbad, CA, United States
Products
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2022

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