FDA Device recall Z-0972-2014
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System by Toshiba American Medical Systems, citing toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be perfo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0972-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-11 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | CA, IN, MD, MN, NY, OH, WI, WV |
Product
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Reason
Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.
Identifiers
| code_info | SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018. |
|---|
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-0972-2014%22
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