BEUDAMED
    FDA Enforcement Class II Terminated

    NeuViz 64 Multi-slice CT Scanner Systems

    Recall: Z-0875-2017 · Reported January 4, 2017

    Enforcement

    Recall Number
    Z-0875-2017
    Event ID
    75383
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neusoft Medical Systems Co., Ltd.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    January 4, 2017
    Initiation Date
    August 31, 2016
    Classification Date
    December 23, 2016
    Termination Date
    January 4, 2018
    Address
    NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang, N/A, N/A, China

    Description

    NeuViz 64 Multi-slice CT Scanner Systems

    Reason

    The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.

    Code Info

    NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version

    Distribution

    US Distribution

    Quantity

    23 units