Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray… — Class II medical device recall Z-3070-2017
Terminated recall by Toshiba American Medical Systems Inc, reported 2017-09-06, distributed in AR, CA, IA, IL, LA, MN, MS, NC…. The issue was identified as a firmware problem with the generator.
| Recall number | Z-3070-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2017-03-15 |
| Classified | 2017-08-30 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2020-09-25 |
| Distributed | AR, CA, IA, IL, LA, MN, MS, NC, NJ, SC, TX, WV, WY |
| Quantity | 18 |
| Reason classes | software |
| Model numbers | DREX-UI80 |
Product
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.
Reason for recall
The issue was identified as a firmware problem with the generator.
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-3070-2017. 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.