BEUDAMED
    FDA Recall Terminated

    GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

    Recall: Z-1291-03 · Initiated May 21, 2003

    Recall

    Recall Number
    Z-1291-03
    Event Number
    26452
    Firm
    GE Medical Systems Information Technologies
    FEI Number
    1030184
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 21, 2003
    Posted
    September 23, 2003
    Terminated
    October 27, 2003
    Address
    4502 Woodland Corporate Blvd., Tampa, FL, 33614

    Description

    GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is

    Reason

    The 2120 Main Board on device lacks required external safety 'watchdog' circuit.

    Action

    The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.

    Distribution

    The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.

    Quantity

    170