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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 07, 2004
Create Date June 25, 2015
Recall Status1 Terminated 3 on February 10, 2012
Recall Number Z-0494-05
Recall Event ID 31217
Product Classification Gauging - Product Code rad
Product X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
Code Information All Serial numbers in domestic distribution.
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information Contact Paul Biggins
714-730-5000
Manufacturer Reason
for Recall		 Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly.
FDA Determined
Cause 2		 Other
Action Firm sent recall letters to customers and will be following up with field corrections which will be made on-site by the firm's own employees.
Quantity in Commerce 494
Distribution 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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