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-2241-2011 · Initiated February 9, 2011

    Recall

    Recall Number
    Z-2241-2011
    Event Number
    58582
    Firm
    Philips And Neusoft Medical Systems Co., Ltd.
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2011
    Posted
    May 23, 2011
    Terminated
    August 24, 2011
    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

    Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.

    Action

    Neusoft Medical Systems sent an Urgent Device Correction Notification letter dated February 9, 2011, via certified mail to their distributor NEUISYS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of combined images. Instead, use MPR Batch for diagnostic reviews until the planned upgrade is provided to the product. Neusoft Medical System and Philips Medical System released the mandatory Field Change Order (FCO) by March 31, 2011. All nine affected systems will be updated with aforementioned kits in six months after the release. Consignees were instructed to contact Service Support Department by e-mail to [email protected]

    Distribution

    Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX.

    Quantity

    9 units distributed in US