TSX-301A/2 Aquilion One CT System — Class II medical device recall Z-2468-2012
Terminated recall by Toshiba American Medical Systems Inc, reported 2012-10-03, distributed nationwide. The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when
| Recall number | Z-2468-2012 |
|---|---|
| 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 | 2008-05-13 |
| Classified | 2012-09-27 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2012-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Serial numbers | 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023 |
| Model numbers | A/2D, TSX-301 |
Product
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
Reason for recall
The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function.
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-2468-2012. 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.