BEUDAMED
    FDA Recall Terminated

    Xoran MiniCAT CT Scanner

    Recall: Z-0037-2014 · Initiated July 27, 2010

    Recall

    Recall Number
    Z-0037-2014
    Event Number
    66337
    Firm
    Xoran Technologies, Inc.
    FEI Number
    3004198450
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 27, 2010
    Terminated
    September 11, 2014
    Address
    5210 S State Rd, Ann Arbor, MI, 48108-7936

    Description

    Xoran MiniCAT CT Scanner

    Reason

    A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu

    Action

    All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.

    Distribution

    Worldwide Distribution - Nationwide

    Quantity

    320