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U.S. Department of Health and Human Services

Class 2 Device Recall Xoran MiniCAT System for ENT

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  Class 2 Device Recall Xoran MiniCAT System for ENT see related information
Date Initiated by Firm September 17, 2008
Date Posted December 23, 2009
Recall Status1 Terminated 3 on December 23, 2009
Recall Number Z-0561-2010
Recall Event ID 47370
510(K)Number K032243  
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI.

Cone beam CT for sinus, temporal bones, and maxillofacial imaging.
Code Information All units.
Recalling Firm/
Manufacturer		 Xoran Technologies, Inc.
309 N 1st St
Ann Arbor MI 48103-3301
For Additional Information Contact
734-663-7194
Manufacturer Reason
for Recall		 The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry motions will both resume.
FDA Determined
Cause 2		 Device Design
Action A letter dated 9/17/08 was sent to each account telling them that the PLC would be upgraded. The firm visited each account and made corrections.
Quantity in Commerce 82
Distribution Nationwide Distribution
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 = JAK and Original Applicant = XORAN TECHNOLOGIES, INC.
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