Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1577-2009

XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which...

Xoran Technologies, LLC / initiated 2009-02-03 / Terminated / root cause: software

Xoran Technologies, Inc. began a recall of 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... on . The reason FDA records is "An incorrect patient name label may appear on the screen displaying the selected patient's scan". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1577-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Xoran Technologies, LLC
Product
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.
Product code
LLZ System, Image Processing, Radiological
Reason for recall
An incorrect patient name label may appear on the screen displaying the selected patient's scan.
Root cause tag
software
FDA root cause
Software design
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.
Quantity in commerce
14
Distribution
Nationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah).
Product codes and lots
Software version 4.1.0.6.