BEUDAMED
    FDA Recall Terminated

    Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.

    Recall: Z-1167-2008 · Initiated January 15, 2008

    Recall

    Recall Number
    Z-1167-2008
    Event Number
    46408
    Firm
    ZOLL Medical Corporation, World Wide Headquarters
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 15, 2008
    Posted
    June 28, 2008
    Terminated
    February 6, 2017
    Address
    269 Mill Rd, Chelmsford, MA, 01824-4105

    Description

    Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.

    Reason

    Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.

    Action

    Consignees were notified by an Urgent Device Correction letter sent on 1/14/08. The letter instructed users to complete and return a response form. Upon receipt of the response form, the recalling firm will have sent a software update. The letter also provided instructions for users to follow in order to avoid the software error before the software update was received. For additional information, contact 1-800-348-9011.

    Distribution

    Worldwide Distribution including USA and countries of Canada, AE, Australia, Belgium, Chile, Germany, Spain, France, UK, Hungary, India, Italy, Jordan, Kuwait, Netherlands, Russia, Saudi Arabia, Singapore and ZA.

    Quantity

    5,018 units