BEUDAMED
    FDA Recall Terminated

    Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.

    Recall: Z-0561-2010 · Initiated September 17, 2008

    Recall

    Recall Number
    Z-0561-2010
    Event Number
    47370
    Firm
    Xoran Technologies, Inc.
    FEI Number
    3004198450
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 17, 2008
    Posted
    December 23, 2009
    Terminated
    December 23, 2009
    Address
    309 N 1st St, Ann Arbor, MI, 48103-3301

    Description

    Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI. Cone beam CT for sinus, temporal bones, and maxillofacial imaging.

    Reason

    The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume.

    Action

    A letter dated 9/17/08 was sent to each account telling them that the PLC would be upgraded. The firm visited each account and made corrections.

    Distribution

    Nationwide Distribution

    Quantity

    82