BEUDAMED
    FDA Recall Terminated

    ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

    Recall: Z-1547-2010 · Initiated March 24, 2010

    Recall

    Recall Number
    Z-1547-2010
    Event Number
    55115
    Firm
    ZOLL Medical Corporation, World Wide Headquarters
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 24, 2010
    Posted
    May 7, 2010
    Terminated
    January 23, 2014
    Address
    269 Mill Rd, Chelmsford, MA, 01824

    Description

    ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

    Reason

    Device issued Shock Advised message but failed to auto-charge the defibrillator.

    Action

    Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.

    Distribution

    Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.

    Quantity

    1383 units