| Class 2 Device Recall Digital Radiography System with Flat Panel Detector | |
Date Initiated by Firm | October 01, 2007 |
Date Posted | November 27, 2007 |
Recall Status1 |
Terminated 3 on April 05, 2012 |
Recall Number | Z-0293-2008 |
Recall Event ID |
45567 |
510(K)Number | K052884 |
Product Classification |
Angiography System - Product Code MQB
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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 CA 92781-2068
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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 | 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 |
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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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510(K) Database | 510(K)s with Product Code = MQB
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