FDA Device recall Z-1068-2013
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray by Toshiba American Medical Systems, citing due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an err….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1068-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-14 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | MD |
Product
Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
Reason
Due to a problem with the control software of the x-ray high-voltage generator, if scanning is performed with a tube current less than 30mA, the control software may detect an error and perform error processing even though the x-ray output is normal.
Identifiers
| code_info | Serial No: 1CB1262006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1068-2013%22
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