BEUDAMED
    FDA Recall Terminated

    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

    Recall: Z-2083-2012 · Initiated June 8, 2012

    Recall

    Recall Number
    Z-2083-2012
    Event Number
    62481
    Firm
    Philips And Neusoft Medical Systems Co., Ltd.
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 8, 2012
    Posted
    July 26, 2012
    Terminated
    September 17, 2012
    Address
    16 Century Road, Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China

    Description

    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

    Reason

    One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.

    Action

    Philips Healthcare North America Company sent an "Urgent Device Correction NeuViz 16 X-Ray Tube Oil-accumulator Detached" letter and attachments of Annex A Method to Identify Affected Products and Annex B Instruction for Mechanic, dated June 14, 2012, to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to follow the instructions on Annex A and Annex B. Philips and Neusoft Medical Systems planned to release the mandatory Field Change Order (FCO) and FCO kits to all customers by the end of June 2012. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems, Co., LTD by e-mail to [email protected]

    Distribution

    Nationwide Distribution -- North Carolina, Ohio, and Texas.

    Quantity

    15 units distributed in the US