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U.S. Department of Health and Human Services

Class 2 Device Recall Xoran MiniCat Model 10004

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  Class 2 Device Recall Xoran MiniCat Model 10004 see related information
Date Initiated by Firm September 08, 2014
Date Posted March 02, 2015
Recall Status1 Terminated 3 on February 02, 2016
Recall Number Z-1210-2015
Recall Event ID 69939
510(K)Number K113421  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Xoran MiniCAT X-ray imaging device
Code Information S/N ENT00031 MiniCAT0020 MiniCAT00361 MiniCAT00358 MiniCAT00150 MiniCAT00310 ENT00006 ENT00055 ENT00059 MiniCAT00140 MiniCAT00305 ENT00014 MiniCAT00148 ENT00039 ENT00076 MiniCAT00409 MiniCAT00179 ENT00014 MiniCAT00215 MiniCAT00309 ENT00035 MiniCAT00158 MiniCAT00386 MiniCAT00202 MiniCAT00324 ENT00127 MiniCAT00352 MiniCAT00396 MiniCAT00194 ENT00080 MiniCAT00171 MiniCAT00244 
Recalling Firm/
Manufacturer		 Xoran Technologies, LLC
5210 S State Rd
Ann Arbor MI 48108-7936
For Additional Information Contact Mark McGarrow
734-663-7194
Manufacturer Reason
for Recall		 Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Xoran Planned Action : A Xoran Technologies service representative will re-measure and perform calibration to correct all affected systems for kVp and dose issues. For the image quality issue, the service representative will mark the black frame and then attempt to reconstruct an adequate image. CDRH also understands that you are continuing your investigation to determine the root cause and a more permanent corrective action for the 3 identified defects. 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. A customer notification letter which includes a statement that Xoran Technologies, LLC will without charge, remedy the defect or bring the product into compliance. 3. Xoran Technologies, LLC will continue to evaluate why the kVp is not always within Xoran specifications, why the unexposed frames continues to occur, and why the dose is not always within Xoran specifications and identify the actions needed to resolve these issues by July 1, 2015. Xoran will communicate the results of this evaluation and any necessary actions to both customers and CDRH. Further questions please call (734) 663-7194.
Quantity in Commerce 432
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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