BEUDAMED
    FDA Recall Terminated

    Neusoft NeuViz 64 Multi-slice CT Scanner System

    Recall: Z-1693-2015 · Initiated March 8, 2014

    Recall

    Recall Number
    Z-1693-2015
    Event Number
    71306
    Firm
    Neusoft Medical System Co
    FEI Number
    3012244921
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 8, 2014
    Posted
    June 16, 2015
    Terminated
    December 5, 2016
    Address
    14425 Torrey Chase Blvd, Ste 100, Houston, TX, 77014-1637

    Description

    Neusoft NeuViz 64 Multi-slice CT Scanner System

    Reason

    The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. Failure is indicated by pin or ring artifact in the image

    Action

    Neusoft planned action: 1. 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. 2. Neusoft Medical Systems Co., Ltd will implement actions to monitor the exposures of the tube and when the exposure number is close to 300,000 seconds, the A-plane compensator will be replaced. The Food and Drug Administration (FDA) district office coordinator should be notified when the last A-plane compensator is replaced. 3. The Customer Information Letter has been sent to customers as a corrective action. The maximum exposure number of 5 US systems is 191830 seconds as of Apr.20, 2015, so the firm will monitor the data continuously and replace the A-plane compensators before the defined threshold. 4. Neusoft will replace all compensators that have exceeded the 300,000 seconds free of charge and will replace all compensators that fail during warranty and the compensators failed less than 300,000 seconds though out of warranty free of charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above) For further questions please call (281) 453-1205

    Distribution

    Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.

    Quantity

    5 installed in US