BEUDAMED
    FDA Recall Terminated

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

    Recall: Z-0876-2017 · Initiated August 31, 2016

    Recall

    Recall Number
    Z-0876-2017
    Event Number
    75383
    Firm
    Neusoft Medical Systems Co., Ltd. NO.
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 31, 2016
    Terminated
    January 4, 2018
    Address
    16 Shiji Road, Hunnan Industrial Area Shenyang China

    Description

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

    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.

    Action

    Neusoft Medical Systems Co. Ltd. planned action to bring into compliance. 1.Affected Customers will be notified by letter to provide them a description of the affected device, instructions for using the device prior to correction, hazards associated with the defect, and a statement of corrective actions to be taken at no cost to the owner. 2.Field Service Engineers will visit owner sites to install a software update which resolves the defect. 3.Corrections will be made at no cost to the owner 4.Corrections will be completed by May 11, 2017. CDRH approves the CAP subject to the following conditions: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call (281) 453-1205.

    Distribution

    US Distribution

    Quantity

    23 units