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U.S. Department of Health and Human Services

Class 2 Device Recall Infinix

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  Class 2 Device Recall Infinix see related information
Date Initiated by Firm September 29, 2008
Date Posted September 28, 2009
Recall Status1 Terminated 3 on October 04, 2012
Recall Number Z-0005-2009
Recall Event ID 53451
510(K)Number K081624  
Product Classification Controller for interventional angiography systems. - Product Code MQB
Product Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Code Information Software version 3.40 or higher
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin CA 92781-2068
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		 Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.
FDA Determined
Cause 2		 Software design
Action Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.
Quantity in Commerce 129
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.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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