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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 Recall
Xoran MiniCAT System for ENT
see related information
Date Posted December 23, 2009
Recall Status1 Terminated on December 23, 2009
Recall Number Z-0561-2010
Recall Event ID 47370
Premarket Notification
510(K) Number
K032243 
Product Classification System, X-Ray, Tomography, Computed - 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, Michigan 48103-3301
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = XORAN TECHNOLOGIES, INC.
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