BEUDAMED
    FDA Recall Terminated

    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    Recall: Z-0883-2009 · Initiated October 21, 2008

    Recall

    Recall Number
    Z-0883-2009
    Event Number
    50119
    Firm
    Zoll Lifecor Corporation
    FEI Number
    3008642652
    Product Code
    MVK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 21, 2008
    Posted
    January 28, 2009
    Terminated
    November 4, 2009
    Address
    121 Freeport Rd, Pittsburgh, PA, 15238-3411

    Description

    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    Reason

    The charging circuit will not shut down properly.

    Action

    Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.

    Distribution

    Nationwide. OUS: Germany, United Kingdom, Italy, and France.

    Quantity

    1685 units