BEUDAMED
    FDA Recall Terminated

    XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device.

    Recall: Z-1577-2009 · Initiated February 3, 2009

    Recall

    Recall Number
    Z-1577-2009
    Event Number
    52171
    Firm
    Xoran Technologies, Inc.
    FEI Number
    3004198450
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 3, 2009
    Posted
    July 9, 2009
    Terminated
    November 19, 2009
    Address
    309 N 1st St, Ann Arbor, MI, 48103-3301

    Description

    XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device.

    Reason

    An incorrect patient name label may appear on the screen displaying the selected patient's scan.

    Action

    The firm released software version 4.1.0.7 by uploading it through a remote software upgrade on February 3, 2009. User accounts were notified by letter dated February 9, 2009. Direct questions to Xoran Technologies at 1-800-709-6726.

    Distribution

    Nationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah).

    Quantity

    14