BEUDAMED
    FDA Recall Terminated

    NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

    Recall: Z-2237-2010 · Initiated July 21, 2008

    Recall

    Recall Number
    Z-2237-2010
    Event Number
    49012
    Firm
    Neuisys, LLC
    FEI Number
    3004971655
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 21, 2008
    Posted
    August 19, 2010
    Terminated
    August 23, 2010
    Address
    1500 Pinecroft Rd, Ste 212, Greensboro, NC, 27407-3808

    Description

    NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

    Reason

    The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.

    Action

    On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China. The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of "Incorrect Reference Line in the Film". When a "Head first, Couch out" or a "Feet first, Couch in" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in "FILM" display mode. The acquired images accurately represent the exact positions planned on the original view. The incorrect/unmatched reference line in film may result in incorrect diagnosis. The consignees are advised not to stop or pause during Surview acquisition while PNMS in China will provide the updated software patch to all affected systems free of charge. The Field Change Order #FCOP-08-CT-NMS-008 SP4 will be implemented by NEUISYS Imaging Systems Solutions in Greensboro, NC., who is a distributor for PNMS. Consignees are advised to e-mail Service Support Department of PNMS at [email protected] regarding the recall.

    Distribution

    Nationwide Distribution

    Quantity

    19 units in the US