Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gast…

Recall date

March 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3070-2017

FDA classification

Class II

Brand / firm

Toshiba American Medical Systems Inc

Sold / distributed

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

Why it was recalled

The issue was identified as a firmware problem with the generator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.