BEUDAMED
    FDA Recall Terminated

    QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.

    Recall: Z-0116-06 · Initiated September 2, 2005

    Recall

    Recall Number
    Z-0116-06
    Event Number
    33327
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 2, 2005
    Posted
    November 2, 2005
    Terminated
    January 17, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.

    Reason

    Potential for voltage pins in connector of therapy cable to break.

    Action

    On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,

    Distribution

    Devices were distributed worldwide.

    Quantity

    total for both types - 52,654