BEUDAMED
    FDA Recall Terminated

    NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.

    Recall: Z-0001-2009 · Initiated April 10, 2008

    Recall

    Recall Number
    Z-0001-2009
    Event Number
    50138
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 10, 2008
    Posted
    January 26, 2009
    Terminated
    October 29, 2010
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.

    Reason

    An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.

    Action

    A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department ([email protected]) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.

    Distribution

    Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.

    Quantity

    19 units in the US.