BEUDAMED
    FDA Recall Terminated

    GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201

    Recall: Z-1155-2008 · Initiated September 4, 2007

    Recall

    Recall Number
    Z-1155-2008
    Event Number
    44884
    Firm
    GE Healthcare Clinical Systems
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    September 4, 2007
    Posted
    June 12, 2008
    Terminated
    May 29, 2012

    Description

    GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201

    Reason

    Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from t

    Action

    GE sent consignees a "GE Urgent Medical Device Correction" letter dated 8/14/07. The letter informed the customers about the problem, offer a short-term workaround and informed them that a representative will schedule a visit to upgrade the software.

    Distribution

    Worldwide Distribution - USA (NY & AL), Korea, China, India, Brazil, Mexico, Germany, Greece, Italy, Poland, Russia, Saudi Arabia, Spain, and Czech Republic.

    Quantity

    62