BEUDAMED
    FDA Recall 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 · Initiated October 18, 2012

    Recall

    Recall Number
    Z-0466-2013
    Event Number
    63553
    Firm
    Philips And Neusoft Medical Systems Co., Ltd.
    FEI Number
    3003575350
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 18, 2012
    Posted
    December 4, 2012
    Terminated
    July 8, 2013
    Address
    16 Century Road, Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning 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.

    Action

    Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at [email protected] For questions regarding this recall call 425-487-7665.

    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