BEUDAMED
    FDA Recall Terminated

    Xoran MiniCAT CT Scanner ID ENT00001

    Recall: Z-0041-2014 · Initiated December 14, 2009

    Recall

    Recall Number
    Z-0041-2014
    Event Number
    66344
    Firm
    Xoran Technologies, Inc.
    FEI Number
    3004198450
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 14, 2009
    Terminated
    September 11, 2014
    Address
    5210 S State Rd, Ann Arbor, MI, 48108-7936

    Description

    Xoran MiniCAT CT Scanner ID ENT00001

    Reason

    Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

    Action

    The service report in response to this complaint stated that the Head select relay board, chip and fan were replaced. The machine (ENTOOOO I) was subsequently tested. All tests were successful.

    Distribution

    Worldwide Distribution - US nationwide

    Quantity

    320