BEUDAMED
    FDA Enforcement Class II Terminated

    Xoran MiniCAT CT Scanner

    Recall: Z-0037-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0037-2014
    Event ID
    66337
    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
    July 27, 2010
    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

    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

    Code Info

    Minicat

    Distribution

    Worldwide Distribution - Nationwide

    Quantity

    320