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Toshiba American Medical Systems Inc recalls Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for g
Recalled September 6, 2017 · FDA recall Z-3070-2017 · Toshiba American Medical Systems
Hazard
The issue was identified as a firmware problem with the generator. · FDA Class II
Units
18
Sold at
US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
Description
The issue was identified as a firmware problem with the generator.
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.
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →