Recall Z-1708-2008 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Med Sys Inc
Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.
| Date | Sep 29, 2008 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 1203 total |
| Distribution | Worldwide distribution, including USA and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982265 | AQUILION CT SCANNER, MODEL TSX-101A Toshiba America Medical Systems, In.C, Aug 26, 1998 |