FDA recall Z-3070-2017

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

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

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