BEUDAMED
    FDA Recall Terminated

    Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.

    Recall: Z-0296-2008 · Initiated July 13, 2006

    Recall

    Recall Number
    Z-0296-2008
    Event Number
    45529
    Firm
    Xoran Technologies, Inc.
    FEI Number
    3004198450
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    July 13, 2006
    Posted
    November 27, 2007
    Terminated
    March 13, 2008
    Address
    309 N 1st St, Ann Arbor, MI, 48103-3301

    Description

    Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.

    Reason

    The hard drive may crash, resulting in loss of data from patient CT scans.

    Action

    Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.

    Distribution

    Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.

    Quantity

    5