BEUDAMED
    FDA Enforcement Class II Ongoing

    LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

    Recall: Z-1232-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1232-2025
    Event ID
    96095
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    February 3, 2025
    Classification Date
    February 25, 2025
    Address
    11811 Willows Rd Ne, N/A, Redmond, WA, 98052-2003, United States

    Description

    LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

    Reason

    Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

    Code Info

    Model/Catalog Number: 99507-000001 UDI-DI code: 00883873813751 Serial Number: 38289467

    Distribution

    U.S.: WV O.U.S.: N/A

    Quantity

    1