Atlas FDA

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

FDA device recall Z-1577-2009 · posted 2009-07-09 · Terminated

Recall details

Recalling firm
Xoran Technologies, Inc.
Reason for recall
An incorrect patient name label may appear on the screen displaying the selected patient's scan.
Action taken
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
Status
Terminated
Product code
LLZ
Quantity affected
14
Distribution
Nationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah).
Date initiated
2009-02-03
Date posted
2009-07-09
Date terminated
2009-11-19
Location
Ann Arbor, MI

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
XORANCONNECT (K073306)Xoran Technologies, Inc.2008-01-07