BEUDAMED
    FDA Recall Open, Classified

    Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

    Recall: Z-2631-2023 · Initiated August 25, 2023

    Recall

    Recall Number
    Z-2631-2023
    Event Number
    93015
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    MNT
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 25, 2023
    Posted
    September 28, 2023
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

    Reason

    Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

    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.

    Distribution

    US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.

    Quantity

    15 (14 US; 1 OUS)