Class 2 Device Recall

• Date Initiated by Firm: March 17, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on November 01, 2011
• Recall Number: Z-1031-04
• Recall Event ID: 29284
• 510(K)Number: K982265 K982787
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: Computed Tomography, Models TSX-101A and TSX-021A.
• Code Information: All Codes
• FEI Number: 2020563
• 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: 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