Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
FDA Recall Z-2631-2023 · Posted 2023-09-28
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Recalling FirmPhilips Respironics, Inc.
Recall StatusOpen, Classified
Product CodeMNT
Date Initiated2023-08-25
Product Quantity15 (14 US; 1 OUS)
Reason for Recall
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Firm 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).
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
Distribution Pattern
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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