# FDA recall Z-3070-2017

> **Toshiba American Medical Systems Inc** · Class II · device recall initiated 2017-03-15.

## 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.

## Distribution

US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.

## Key facts

- **Recall number:** Z-3070-2017
- **Recalling firm:** Toshiba American Medical Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-03-15
- **Report date:** 2017-09-06
- **Termination date:** 2020-09-25

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3070-2017

## Citation

> AI Analytics. FDA recall Z-3070-2017. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-3070-2017. Source: US FDA. Licensed CC0.

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