TSX-301C Aquilion One — Class II medical device recall Z-0972-2014
Terminated recall by Toshiba American Medical Systems Inc, reported 2014-03-12, distributed in CA, IN, MD, MN, NY, OH, WI, WV. Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray
| Recall number | Z-0972-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2013-12-11 |
| Classified | 2014-03-06 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-10-16 |
| Distributed | CA, IN, MD, MN, NY, OH, WI, WV |
| Quantity | 8 units |
| Serial numbers | 1CB1262006, 1CB12X2018, 1DB1312027, 1DB1312033, 1DB1332045, 1DB1332049, 1DB1342060, 1DC1352070, 1DC1362073, 1DC1382081 |
Product
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0972-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.