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U.S. Department of Health and Human Services

Class 2 Device Recall Infinix

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 Class 2 Recall
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Date Posted September 28, 2009
Recall Status1 Open
Recall Number Z-0005-2009
Recall Event ID 53451
Premarket Notification
510(K) Number
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - 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/
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
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
DESIGN: Device 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.