BEUDAMED
    FDA Enforcement Class II 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 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2401-2012
    Event ID
    63004
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ZOLL Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 26, 2012
    Initiation Date
    August 16, 2012
    Classification Date
    September 17, 2012
    Termination Date
    September 19, 2012
    Address
    269 Mill Road, Chelmsford, MA, 01824, United States

    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

    Code Info

    Serial Numbers: AR11J000164, AR12E000853, AR12E000856, AR12E000868, AR12E000920, AR12E000922, AR12E000923, AR12E000931, AR12E000944 AR12F001100, AR12F001298,

    Distribution

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

    Quantity

    11 units