BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1650-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1650-2016
    Event ID
    73832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neusoft Medical Systems Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    May 2, 2015
    Classification Date
    May 11, 2016
    Termination Date
    November 4, 2016
    Address
    NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang, N/A, N/A, 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.

    Code Info

    Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E

    Distribution

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

    Quantity

    7 units