BEUDAMED
    FDA Enforcement Class II Ongoing

    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

    Recall: Z-2499-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2499-2025
    Event ID
    96949
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 10, 2025
    Initiation Date
    July 22, 2025
    Classification Date
    September 2, 2025
    Address
    11811 Willows Rd Ne, N/A, Redmond, WA, 98052-2003, United States

    Description

    LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

    Reason

    Due to required inspections not being performed on products/units that have gone through servicing.

    Code Info

    Part / Catalog Numbers / UDI-DI code / Serial Number: CR2-2-001451 / 99512-001434 / 883873785911 / 49638156

    Distribution

    U.S. Nationwide distribution in the states of CO and MT.

    Quantity

    1 unit