BEUDAMED
    FDA Recall Terminated

    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.

    Recall: Z-1573-2016 · Initiated March 24, 2016

    Recall

    Recall Number
    Z-1573-2016
    Event Number
    73741
    Firm
    Philips and Neusoft Medical Systems Co., Ltd. No. 2 Xiu xiu Street Hunnan; Sujiatun Shenyang China
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 24, 2016
    Posted
    April 27, 2016
    Terminated
    November 23, 2016

    Description

    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.

    Reason

    The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be

    Action

    Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.

    Distribution

    NC, OH, NE, SC, TX, LA, PR, MO, FL, CT

    Quantity

    37 units