BEUDAMED
    FDA Enforcement Class II Terminated

    NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

    Recall: Z-1166-2013 · Reported May 1, 2013

    Enforcement

    Recall Number
    Z-1166-2013
    Event ID
    64783
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips And Neusoft Medical Systems Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2013
    Initiation Date
    March 4, 2013
    Classification Date
    April 23, 2013
    Termination Date
    November 22, 2013
    Address
    16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning, N/A, China

    Description

    NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.

    Reason

    User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

    Code Info

    Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.

    Distribution

    Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.

    Quantity

    25 units