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U.S. Department of Health and Human Services

Class 2 Device Recall XORANCONNECT

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 Class 2 Recall
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Date Posted July 09, 2009
Recall Status1 Terminated on November 19, 2009
Recall Number Z-1577-2009
Recall Event ID 52171
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product XoranConnect, software version, 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.
Code Information Software version
Recalling Firm/
Xoran Technologies, Inc.
309 N 1st St
Ann Arbor, Michigan 48103-3301
Manufacturer Reason
for Recall
An incorrect patient name label may appear on the screen displaying the selected patient's scan.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm released software version 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).
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = XORAN TECHNOLOGIES, INC.