BEUDAMED
    FDA Recall Terminated

    FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

    Recall: Z-0036-06 · Initiated September 13, 2005

    Recall

    Recall Number
    Z-0036-06
    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 HCS (Home Care 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

    13 units