BEUDAMED
    FDA Recall Terminated

    MAC-LAB (Classic) systems

    Recall: Z-0786-03 · Initiated April 14, 2003

    Recall

    Recall Number
    Z-0786-03
    Event Number
    25951
    Firm
    General Electric Medical Systems Information Technology
    FEI Number
    2124823
    Product Code
    KMI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2003
    Posted
    April 25, 2003
    Terminated
    June 24, 2004
    Address
    8200 W. Tower, Milwaukee, WI, 53223

    Description

    MAC-LAB (Classic) systems

    Reason

    There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.

    Action

    A letter was sent to the consignees on April 14, 2003 and requested that the consignees correct the device or contact the firm to have them perform the correction.

    Distribution

    The recalled products were shipped to hospitals located nationwide in the United States and to other consignees located worldwide.