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U.S. Department of Health and Human Services

Class 2 Device Recall Xoran MiniCAT for ENT.

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 Class 2 Recall
Xoran MiniCAT for ENT.
see related information
Date Posted November 27, 2007
Recall Status1 Terminated on March 13, 2008
Recall Number Z-0296-2008
Recall Event ID 45529
Premarket Notification
510(K) Number
K032243 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Xoran MiniCAT for ENT, Xoran Technologies, Incorporated, Ann Arbor, MI 48103. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging.
Code Information Serial Numbers: ENT00009, ENT00051, ENT00084, ENT00086 and ENT00088.
Recalling Firm/
Manufacturer
Xoran Technologies, Inc.
309 N 1st St
Ann Arbor, Michigan 48103-3301
Manufacturer Reason
for Recall
The hard drive may crash, resulting in loss of data from patient CT scans.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Finished Device Change Control
Action Consignee accounts were visited between 7/25/06 and 8/10/07 and the hard drives on their systems were replaced.
Quantity in Commerce 5
Distribution Nationwide Distribution: California, South Dakota, Tennessee, Utah and West Virginia.
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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