BEUDAMED
    FDA Recall Terminated

    LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.

    Recall: Z-0671-2007 · Initiated March 2, 2007

    Recall

    Recall Number
    Z-0671-2007
    Event Number
    37490
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 2, 2007
    Posted
    March 29, 2007
    Terminated
    April 26, 2012
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.

    Reason

    LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.

    Action

    Firm sent letters on 03/02/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK CR Plus devices. The firm advised consignees to upgrade their devices' software, and indicated that each consignee will be provided a user-installable software upgrade for their device(s) within 45 days.

    Distribution

    Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.

    Quantity

    13,835 units