Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- October 1, 2007
- Posted
- September 29, 2008
- Terminated
- July 16, 2012
- Recall Number
- Z-1708-2008
- Quantity
- 1203 total
- Firm Location
- Tustin, CA
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.
Distribution
Worldwide distribution, including USA and Japan.
Lot / Code Info
All codes
Root Cause
Device Design
Action Taken
Toshiba sent a letter to customers in July 2007, and sent field service representatives to update the Data Aquisition System in September/October 2007.
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