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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 March 17, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 01, 2011
Recall Number Z-1031-04
Recall Event ID 29284
510(K)Number k982787  k982265  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Computed Tomography,

Models TSX-101A and TSX-021A.
Code Information All Codes
Recalling Firm/
Manufacturer		 Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
Manufacturer Reason
for Recall		 Erroneous patient data is entered. Previoius patient's demographics are recorded.
FDA Determined
Cause 2		 Software design
Action Firm issued Field Modification Instruction which describes the action to be taken by the firm''s own service technicians. Recall letters were sent to each site informing of the issue and provide caution regarding the problem prior to it''s getting fixed.
Quantity in Commerce 552
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 = JAK and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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