Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
This recall is currently active, issued September 28, 2023. It was issued by Philips Respironics, Inc..
- Company
- Philips Respironics, Inc.
- Recall Initiated
- August 25, 2023
- Posted
- September 28, 2023
- Recall Number
- Z-2631-2023
- Quantity
- 15 (14 US; 1 OUS)
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Distribution
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Lot / Code Info
V60 Device Serial # /PCBA Serial # 201019564 SC23120K8 201014394 SC23120NH 201017048 SC2312133 100246411 SC231116C 100246416 SC231117H 100085632 SC2311127 100013579 SC23110EV 100082334 SC2311138 ***Updated November 6, 2023*** 100423818 SC2311168 100293267 SC2312154 100006900 SC2311165 100006889 SC23110MF 201010175 SC231104X (Philippines) ***Updated July 23, 2024*** 100385387 SC231108T 201029990 SC2311055
Root Cause
Nonconforming Material/Component
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.