BEUDAMED
    FDA Recall Terminated

    LIFEPAK EXPRESS defibrillator

    Recall: Z-0837-2007 · Initiated October 5, 2006

    Recall

    Recall Number
    Z-0837-2007
    Event Number
    36484
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 5, 2006
    Posted
    June 21, 2007
    Terminated
    August 8, 2013
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK EXPRESS defibrillator

    Reason

    Premature battery depletion due to electrical component failure

    Action

    Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.

    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, and public libraries.

    Quantity

    Total of Express 1,006 units worldwide; amount does not include units distributed to Japan.