BEUDAMED
    FDA Recall Terminated

    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

    Recall: Z-1650-2016 · Initiated May 2, 2015

    Recall

    Recall Number
    Z-1650-2016
    Event Number
    73832
    Firm
    Neusoft Medical Systems Co., Ltd. NO.
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 2, 2015
    Terminated
    November 4, 2016
    Address
    16 Shiji Road, Hunnan Industrial Area Shenyang China

    Description

    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

    Reason

    It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.

    Action

    An upgraded software version (1.0.5.2619+P11) was released on May 7, 2015. The FCO was released to the service engineers of Neusoft Medical Systems USA, which is subsidiary of the reporting firm, and the engineers performed FCO for each affected device together with the distributors' engineers. The corrections (FCOs to upgrade software) on all the affected systems in the USA have been completed. At present (4/27/16) there is no longer this issue on the systems, so no further actions are needed for customers/distributors. However, the recalling firm shall inform the direct accounts of this fix before May 5, 2016. The recalling firm will submit the communication evidence ASAP once they have evidence of the communication. For further questions, please call (281) 453-1205.

    Distribution

    US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE

    Quantity

    7 units