BEUDAMED
    FDA Recall Terminated

    Zoll AED Plus Defibrillator

    Recall: Z-1206-2009 · Initiated February 12, 2009

    Recall

    Recall Number
    Z-1206-2009
    Event Number
    51053
    Firm
    ZOLL Medical Corporation, World Wide Headquarters
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 12, 2009
    Posted
    April 1, 2009
    Terminated
    April 9, 2026
    Address
    269 Mill Rd, Chelmsford, MA, 01824

    Description

    Zoll AED Plus Defibrillator

    Reason

    Device fails to discharge the defibrillation energy.

    Action

    On 3/31/09, the firm revised their recall strategy and required all users to a perform a "Mandatory Upgrade" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009. In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update their devices with software that will monitor batteries for the identified defect. ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/

    Distribution

    Worldwide distribution

    Quantity

    183,535 units