BEUDAMED
    FDA Enforcement Class II Ongoing

    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

    Recall: Z-0567-2024 · Reported December 27, 2023

    Enforcement

    Recall Number
    Z-0567-2024
    Event ID
    93234
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2023
    Initiation Date
    November 6, 2023
    Classification Date
    December 15, 2023
    Address
    11811 Willows Rd Ne, N/A, Redmond, WA, 98052-2003, United States

    Description

    AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

    Reason

    AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

    Code Info

    UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

    Quantity

    18,732