BEUDAMED
    FDA Recall Terminated

    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

    Recall: Z-0263-2016 · Initiated September 14, 2015

    Recall

    Recall Number
    Z-0263-2016
    Event Number
    72171
    Firm
    NeuroLogica Corporation
    FEI Number
    3004938766
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 14, 2015
    Posted
    November 10, 2015
    Terminated
    January 19, 2017
    Address
    14 Electronics Ave, Danvers, MA, 01923-1011

    Description

    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

    Reason

    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.

    Action

    An Urgent - Field Safety Notice identifying the affected products, problem involved, root cause, and potential hazards, was sent to customers. In the event the issue occurs, users can release the drive handle or press the emergency switch and the unit will stop. Then, reboot the system. If unintended movements occur, please contact local representative. To correct the issue, service engineers will visit to apply the corrective action. For further information or support concerning this problem, contact local representative.

    Distribution

    Distributed to the states of NC, OH, MA, and MO.

    Quantity

    7 devices