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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 June 18, 2004
Date Posted August 11, 2004
Recall Status1 Terminated 3 on March 15, 2005
Recall Number Z-1337-04
Recall Event ID 29438
510(K)Number k013608  
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Digital Radiography System, model DFP-8000D
Code Information All codes
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
For Additional Information Contact Michaela Mahl
714-730-5000
Manufacturer Reason
for Recall		 Defect in the mirroring unit.
FDA Determined
Cause 2		 Other
Action An advisory letter will be sent to all users 6/24/2004. An order was issued to correct the firmware problem.
Quantity in Commerce 19
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 = JAA and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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