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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Radiography System with Flat Panel Detector

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 Class 2 Recall
Digital Radiography System with Flat Panel Detector
see related information
Date Posted November 27, 2007
Recall Status1 Open
Recall Number Z-0293-2008
Recall Event ID 45567
Premarket Notification
510(K) Number
K052884 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780
Code Information Serial numbers: B5522165, W1C0562187, W1C0572197, W1C0572202, W1C0622275, W1C0622270, A3632065, A3622066, W1C0456192, W1C0632284, W1D0722373, W1D0742386, B5512160, W1C0592213, W1C0592215, A4562099, W1C05Z2254, B4582113, W1C0642289, W1D0697015, W1C0552182, W1C05X2224, W1D0742387
Recalling Firm/
Manufacturer
Toshiba American Med Sys Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
For Additional Information Contact Paul Biggins
714-730-5000
Manufacturer Reason
for Recall
System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
FDA Determined
Cause 2
DESIGN: Software Design
Action Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.
Quantity in Commerce 23
Distribution Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV
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.
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