BEUDAMED
    FDA Recall Terminated

    AccessAED Package (without audio record) Model Number: 9100-0150-0

    Recall: Z-0200-05 · Initiated November 3, 2004

    Recall

    Recall Number
    Z-0200-05
    Event Number
    30378
    Firm
    Access CardioSystems
    FEI Number
    3003585458
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2004
    Posted
    November 20, 2004
    Terminated
    April 12, 2006
    Address
    150 Baker Avenue, Ste 108, Concord, MA, 01742-2196

    Description

    AccessAED Package (without audio record) Model Number: 9100-0150-0

    Reason

    Device may fail to deliver shock due to a faulty circuit board

    Action

    AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation.

    Distribution

    Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore

    Quantity

    2995 units