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.
FDA Recall Z-1577-2009 · Posted 2009-07-09
Advertisement
Recalling FirmXoran Technologies, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-02-03
Date Terminated2009-11-19
Product Quantity14
Reason for Recall
An incorrect patient name label may appear on the screen displaying the selected patient's scan.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement