Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray system.
FDA device recall Z-1707-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1203 total
- Distribution
- Worldwide distribution, including USA and Japan.
- Date initiated
- 2007-10-01
- Date posted
- 2008-09-29
- Date terminated
- 2012-07-16
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUILION CT SCANNER, MODEL TSX-101A (K982265) | Toshiba America Medical Systems, In.C | 1998-08-26 |