BEUDAMED
    FDA Recall Terminated

    LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.

    Recall: Z-0386-06 · Initiated September 2, 2004

    Recall

    Recall Number
    Z-0386-06
    Event Number
    33266
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 2, 2004
    Posted
    January 11, 2006
    Terminated
    January 5, 2007
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.

    Reason

    The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.

    Action

    Devices will have software upgrades done by GE Field Service Technicians. The upgrade will include a dialog box which will display on the screen when prior data exists and a new patient is being registered.

    Distribution

    nationwide and worldwide

    Quantity

    393