BEUDAMED
    FDA Enforcement Class II Terminated

    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    Recall: Z-3044-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3044-2017
    Event ID
    77608
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neusoft Medical Systems Co., Ltd.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 6, 2017
    Initiation Date
    May 19, 2017
    Classification Date
    August 28, 2017
    Termination Date
    November 19, 2020
    Address
    NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang, N/A, N/A, China

    Description

    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    Reason

    Software defect

    Code Info

    NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version

    Distribution

    US Nationwide distribution

    Quantity

    234