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Class 2 Device Recall Xoran MiniCAT System for ENT |
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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
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Product Classification |
Computed Tomography X-Ray System - Product Code JAK
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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
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For Additional Information Contact |
734-663-7194
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = XORAN TECHNOLOGIES, INC.
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