TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System — Class II medical device recall Z-1113-2014
Terminated recall by Toshiba American Medical Systems Inc, reported 2014-03-12, distributed nationwide. Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output
| Recall number | Z-1113-2014 |
|---|---|
| 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 | 2013-10-01 |
| Classified | 2014-03-03 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2015-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 338 units |
| Reason classes | software |
| Serial numbers | 1DA0962006, 1DA0972007, 1DA0972008, 1DA0992011, 1DA09Y2014, 1DA1062015, 1DA1222096, 1DA1222097, 1DA1232099, 1DA1232100, 1DA1232103, 1DA1252124, 1DA1252131, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019, 1DB10Y2020, 1DB10Y2021, 1DB10Y2022, 1DB1112025, 1DB1122027, 1DC1142030, 1DC1152031, 1DC1162032 and 316 more |
Product
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Reason for recall
Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start.
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-1113-2014. 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.