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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 XORANCONNECTsee related information
Date Initiated by FirmFebruary 03, 2009
Date PostedJuly 09, 2009
Recall Status1 Terminated 3 on November 19, 2009
Recall NumberZ-1577-2009
Recall Event ID 52171
510(K)NumberK073306 
Product Classification System, image processing, radiological - Product Code LLZ
ProductXoranConnect, 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
ActionThe 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 Commerce14
DistributionNationwide Distribution (Alabama, Arizona, Colorado, Georgia, Illinois, Louisiana, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas and Utah).
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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