BEUDAMED
    FDA Recall Terminated

    Xoran MiniCAT X-ray imaging device

    Recall: Z-1210-2015 · Initiated September 8, 2014

    Recall

    Recall Number
    Z-1210-2015
    Event Number
    69939
    Firm
    Xoran Technologies, LLC
    FEI Number
    3004198450
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    September 8, 2014
    Posted
    March 2, 2015
    Terminated
    February 2, 2016
    Address
    5210 S State Rd, Ann Arbor, MI, 48108-7936

    Description

    Xoran MiniCAT X-ray imaging device

    Reason

    Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

    Action

    Xoran Planned Action : A Xoran Technologies service representative will re-measure and perform calibration to correct all affected systems for kVp and dose issues. For the image quality issue, the service representative will mark the black frame and then attempt to reconstruct an adequate image. CDRH also understands that you are continuing your investigation to determine the root cause and a more permanent corrective action for the 3 identified defects. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. A customer notification letter which includes a statement that Xoran Technologies, LLC will without charge, remedy the defect or bring the product into compliance. 3. Xoran Technologies, LLC will continue to evaluate why the kVp is not always within Xoran specifications, why the unexposed frames continues to occur, and why the dose is not always within Xoran specifications and identify the actions needed to resolve these issues by July 1, 2015. Xoran will communicate the results of this evaluation and any necessary actions to both customers and CDRH. Further questions please call (734) 663-7194.

    Distribution

    Nationwide Distribution

    Quantity

    432