Recall Z-2631-2023 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Philips Respironics, Inc.
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
| Date | Sep 28, 2023 (initiated Aug 25, 2023) |
| Status | Open, Classified |
| Reason | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. |
| Root cause | Nonconforming Material/Component |
| Action | Impacted customers were contacted via phone and email on August 25, 2023. Philips released an "Urgent Medical Device Correction" customer letter to make customers aware of the potential for a power failure leading to ventilator loss of function. Instructions to Customer Discontinue use of and quarantine these device(s) until you are contacted by a Philips Respironics representative to remove and/or replace the Power Management PCBAs in the affected device(s). Philips Respironics will contact you to coordinate a time to remove and/or replace the impacted component located within your device(s |
| Quantity | 15 (14 US; 1 OUS) |
| Distribution | US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics, Inc., Apr 5, 2011 |