Respironics California, LLC Recall 89767
Description: Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
Respironics California, LLC Recall 89767 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0909-2022 |
| Event ID | 89767 |
| Event Description | Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States |
| Product Type | Devices |
| 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. |
| Recall 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. |
| Device Classification | 20220427 |
| Device Code Info | All Lots & Serial Numbers ; *Distributed outside the Untied States |
| Center Classification Date | 20220418 |
| Recall Initiation Date | 20220228 |
| Recalling Firm | Respironics California, LLC |
| Initial Notification | Letter |
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