Class 2 Device Recall Aquilion

• Date Initiated by Firm: October 01, 2007
• Date Posted: September 29, 2008
• Recall Status: Terminated on July 16, 2012
• Recall Number: Z-1708-2008
• Recall Event ID: 49541
• 510(K)Number: K982265
• Product Classification: computed tomography x-ray system - Product Code JAK
• Product: Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.
• Code Information: All codes
• FEI Number: 2020563
• Recalling Firm/ Manufacturer: Toshiba American Med Sys Inc; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: 714-730-5000
• Manufacturer Reason for Recall: Excessive radiation: Intermittent shifting of CT numbers causes the actual dose to the patient to be greater than expected, when Sure Exposure option is used.
• FDA Determined Cause: Device Design
• Action: Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.
• Quantity in Commerce: 1203 total
• Distribution: Worldwide distribution, including USA and Japan.
• 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