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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilion

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  Class 2 Device Recall Aquilion see related information
Date Initiated by Firm October 01, 2007
Date Posted September 29, 2008
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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