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U.S. Department of Health and Human Services

Class 2 Device Recall MiniCAT CT Scanner

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  Class 2 Device Recall MiniCAT CT Scanner see related information
Date Initiated by Firm December 14, 2009
Create Date June 26, 2015
Recall Status1 Terminated 3 on September 11, 2014
Recall Number Z-0041-2014
Recall Event ID 66344
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Xoran MiniCAT CT Scanner ID ENT00001
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		 Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The service report in response to this complaint stated that the Head select relay board, chip and fan were replaced. The machine (ENTOOOO I) was subsequently tested. All tests were successful.
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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