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U.S. Department of Health and Human Services

Class 2 Device Recall Cone Beam CT Scanner ( CBCT)

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  Class 2 Device Recall Cone Beam CT Scanner ( CBCT) see related information
Date Initiated by Firm July 27, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on September 11, 2014
Recall Number Z-0036-2014
Recall Event ID 66335
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Xoran Mini CT Scanner
Code Information Minicat
Recalling Firm/
Manufacturer		 Xoran Technologies, Inc.
5210 S State Rd
Ann Arbor MI 48108-7936
For Additional Information Contact
734-663-7194
Manufacturer Reason
for Recall		 A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action All of the MiniCAT CT Scanners subject to these complaints were serviced by Xoran technicians and the out-of-specifications devices were brought into specification. This was accomplished by either readjusting the settings or by installing a new component.
Quantity in Commerce 320
Distribution Worldwide Distribution - US nationwide
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.
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