TSX-IOI: AQUILION 32/64 — Class II medical device recall Z-1067-2013
Terminated recall by Toshiba American Medical Systems Inc, reported 2013-04-17, distributed nationwide. The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be d
| Recall number | Z-1067-2013 |
|---|---|
| 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 | 2011-11-30 |
| Classified | 2013-04-07 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2013-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 23 units |
| Reason classes | software |
| Serial numbers | HDA0722595, JDA0972130, JDA0972135, JDA0992147, JDA09Y2157, JDA09Y2158, JDA09Y2161, JDA1012171, JDA1072183, JDA1082189, JDA10X2191, JDA10X2197, JDA10Z2214, JDA1182241, JDA1182242, JDA1182244, JDAL112216, JDAL112219, JGAL112220, JLA1122232, JLA1132235, KDA09X2063, NLA0972032 |
Product
TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
Reason for recall
The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) value may be displayed incorrectly when the vHP option is used.
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-1067-2013. 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.