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.
|