| Class 2 Device Recall Xoran MiniCAT System for ENT | |
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
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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 |
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 |
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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
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