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U.S. Department of Health and Human Services

Class 2 Device Recall XORANCONNECT

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  Class 2 Device Recall XORANCONNECT see related information
Date Initiated by Firm February 03, 2009
Date Posted July 09, 2009
Recall Status1 Terminated 3 on November 19, 2009
Recall Number Z-1577-2009
Recall Event ID 52171
510(K)Number K073306  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information Software version 4.1.0.6.
Recalling Firm/
Manufacturer		 Xoran Technologies, Inc.
309 N 1st St
Ann Arbor MI 48103-3301
For Additional Information Contact
800-709-6726
Manufacturer Reason
for Recall		 An incorrect patient name label may appear on the screen displaying the selected patient's scan.
FDA Determined
Cause 2		 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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = XORAN TECHNOLOGIES, INC.
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