BEUDAMED
    FDA Recall Terminated

    Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).

    Recall: Z-2401-2012 · Initiated August 16, 2012

    Recall

    Recall Number
    Z-2401-2012
    Event Number
    63004
    Firm
    ZOLL Medical Corporation
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 16, 2012
    Posted
    September 17, 2012
    Terminated
    September 19, 2012
    Address
    269 Mill Road, Chelmsford, MA, 01824

    Description

    Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).

    Reason

    Shipped with incorrect software

    Action

    Zoll Medical telephoned affected customers on August 16, 2012. Customers were informed of the affected product, problem and actions to be taken. Customers were instructed to remove and return the affected product for replacement. For question contact ZOLL's Technical Support.

    Distribution

    Worldwide Distribution - US Nationwide including the states of: LA, MA, ME, NC, ND, NE, OH and the country of Germany.

    Quantity

    11 units