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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 July 27, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on September 11, 2014
Recall Number Z-0039-2014
Recall Event ID 66338
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Xoran Minicat00158
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		 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 evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha
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. Xoran's Research & Development group is evaluating the current specification to see if the field specifications are appropriate and to ensure that proper testing protocols are communicated and are in place for use by 3 rd party testing organizations. In addition, Xoran has initiated CAPA # 18 0 that is looking at the source block with regard to evaluating the stability of the dose rating.
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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