BEUDAMED
    FDA Recall Terminated

    FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)

    Recall: Z-0035-06 · Initiated September 13, 2005

    Recall

    Recall Number
    Z-0035-06
    Event Number
    33337
    FEI Number
    1220672
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 13, 2005
    Posted
    October 12, 2005
    Terminated
    August 7, 2006
    Address
    8 Centennial Drive, Analogic Corporation Centennial Industrial park, Peabody, MA, 01960-7902

    Description

    FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)

    Reason

    Unit may not power up due to faulty circuit board

    Action

    Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.

    Distribution

    CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia

    Quantity

    37 units