BEUDAMED
    FDA Enforcement Class II Terminated

    Xoran MiniCAT CT Scanner ID ENT00001

    Recall: Z-0041-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0041-2014
    Event ID
    66344
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xoran Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    December 14, 2009
    Classification Date
    October 25, 2013
    Termination Date
    September 11, 2014
    Address
    5210 S State Rd, N/A, Ann Arbor, MI, 48108-7936, United States

    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.

    Code Info

    minicat

    Distribution

    Worldwide Distribution - US nationwide

    Quantity

    320