BEUDAMED
    FDA Recall Terminated

    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device 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-0846-2011 · Initiated February 10, 2010

    Recall

    Recall Number
    Z-0846-2011
    Event Number
    54638
    Firm
    Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2010
    Posted
    January 4, 2011
    Terminated
    April 15, 2011

    Description

    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.

    Reason

    Potential for the CT patient table top to become detached from the carrier due to missing washers.

    Action

    Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees. The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury. Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at [email protected] or Service Support Department at [email protected] for questions about this recall.

    Distribution

    Nationwide Distribution including NC

    Quantity

    26 devices