BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-2631-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2631-2023
    Event ID
    93015
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 4, 2023
    Initiation Date
    August 25, 2023
    Classification Date
    September 28, 2023
    Address
    1001 Murry Ridge Ln, N/A, Murrysville, PA, 15668-8517, United States

    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.

    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

    Distribution

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

    Quantity

    15 (14 US; 1 OUS)