BEUDAMED
    FDA Recall Terminated

    LIFEPAK EXPRESS defibrillator

    Recall: Z-0548-06 · Initiated January 31, 2006

    Recall

    Recall Number
    Z-0548-06
    Event Number
    34534
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 31, 2006
    Posted
    February 23, 2006
    Terminated
    January 17, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK EXPRESS defibrillator

    Reason

    One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

    Action

    On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.

    Distribution

    Units were distributed worldwide to public access environments.

    Quantity

    20,525 devices total - CR Plus and LIFEPAK Express