Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 113
FDA device recall Z-2631-2023 · posted 2023-09-28 · Open, Classified
Recall details
- Recalling firm
- Philips Respironics, Inc.
- Reason for recall
- Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
- Action taken
- 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). If you need any further information or support with this issue, please contact your local Philips Respironics representative, or call the Philips Respironics Customer Care Solutions Center at 1 (800) 722-9377. ***Updated November 2023*** Customers of the additional impacted PCBAs were contacted via phone and email on November 3, 2023.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MNT
- Quantity affected
- 15 (14 US; 1 OUS)
- Distribution
- US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
- Date initiated
- 2023-08-25
- Date posted
- 2023-09-28
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (K102985) | Respironics, Inc. | 2011-04-05 |