Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT… — Class II medical device recall Z-0622-2017
Terminated recall by Toshiba American Medical Systems Inc, reported 2016-11-30, distributed nationwide. Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that
| Recall number | Z-0622-2017 |
|---|---|
| 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 | 2016-10-25 |
| Classified | 2016-11-18 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 291 units |
| Reason classes | packaging |
Product
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
Reason for recall
Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
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-0622-2017. 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.