BEUDAMED
    FDA Recall Terminated

    Zoll M Series External Defibrillator

    Recall: Z-1000-03 · Initiated June 23, 2003

    Recall

    Recall Number
    Z-1000-03
    Event Number
    26590
    Firm
    Zoll Medical Corporation
    FEI Number
    1220908
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2003
    Posted
    July 10, 2003
    Terminated
    December 29, 2020
    Address
    32 Second Avenue, Burlington, MA, 01803

    Description

    Zoll M Series External Defibrillator

    Reason

    Defibrillator may fail to charge or hold its charge above energies of 75 joules

    Action

    Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.

    Distribution

    Nationwide Foreign: Emirates, Australia, Brussels, Brazil, Canada, China, Columbia, Chezche, Germany, Spain, Finland, France, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, Mexico, Netherlands, Poland,Romania, Saudi Arabia, Syrai, Thailand, Turkey,

    Quantity

    8,142 units