BEUDAMED
    FDA Enforcement Class II Terminated

    NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as 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-0466-2013 · Reported December 12, 2012

    Enforcement

    Recall Number
    Z-0466-2013
    Event ID
    63553
    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
    December 12, 2012
    Initiation Date
    October 18, 2012
    Classification Date
    December 4, 2012
    Termination Date
    July 8, 2013
    Address
    16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning, N/A, N/A, China

    Description

    NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as 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 four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.

    Code Info

    NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual 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 including North Carolina, Ohio, Texas, and Puerto Rico.

    Quantity

    20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series