BEUDAMED
    FDA Recall Terminated

    Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

    Recall: Z-3036-2017 · Initiated May 24, 2017

    Recall

    Recall Number
    Z-3036-2017
    Event Number
    77384
    Firm
    NeuroLogica Corporation
    FEI Number
    3004938766
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 24, 2017
    Terminated
    July 9, 2018
    Address
    14 Electronics Ave, Danvers, MA, 01923-1011

    Description

    Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications

    Reason

    When performing the Stitching function on GU60A system, unintended area is exposed to radiation

    Action

    Neurologica will bring defect into compliance : 1.All facilities were notified via a customer notification letter. 2.Samsung will release improved software to avoid unintended exposure. When setting the stitching area, if there is an over exposed area, the height of the swivel arm will be lowered over the exposed area and the first region (first image) will be collimated by the bottom blade. 3.A software patch was developed: SW3.01 was released on 05/08/2017 and SW1.00 was released on 07/28/17. 4.The software patch will be installed on the affected devices. 5.Samsung has provided the statement and assurance that all corrections will be performed free of charge. 6.All units will be provided with updated software by November 11, 2017. For further questions, please call (978) 564-8500.

    Distribution

    Nationwide Distribution

    Quantity

    87 units