BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-0907-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0907-2022
    Event ID
    89767
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Respironics California, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    February 28, 2022
    Classification Date
    April 18, 2022
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92011-1517, United States

    Description

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

    Reason

    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.

    Code Info

    All Lots & Serial Numbers. V60 UDI-DI: 00884838009844, 00884838009851, 00884838020054, 00884838025776, 00884838089280, 00884838090996.

    Distribution

    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.

    Quantity

    87,138 units