FDA Device recall Z-3070-2017
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies… by Toshiba American Medical Systems, citing the issue was identified as a firmware problem with the generator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3070-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-15 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | AR, CA, IA, IL, LA, MN, MS, NC, NJ, SC, TX, WV, WY |
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
The issue was identified as a firmware problem with the generator.
Identifiers
| code_info | Ser. No. U1A1692606 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3070-2017%22
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