Recall Z-0909-2022 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California, LLC
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
| Date | Apr 18, 2022 (initiated Feb 28, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On March 14, 2022, Respironics California, LLC issued an Urgent Medical Device Correction notification to all affected consignees. On April 28, 2022 Respironics issued a revised customer communication titled Update: Urgent Medical Device Correction, dated April 20, 2022, which described mitigating actions. On June 30, 2022, Respironics issued an Updated Urgent Medical Device Correction Notification. This letter was to provide customers with an update on Philips Respironics actions to address an issue related to the internal source (35V Rail) that powers the V60/V60 Plus ventilators. In additi |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.