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.
FDA Recall Z-3070-2017 · Posted None
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-03-15
Date Terminated2020-09-25
Product Quantity18
Reason for Recall
The issue was identified as a firmware problem with the generator.
Firm Action
Toshiba America Medical Systems ( TAMS) will bring the defect into Compliance:
1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made.
2.You will install modified firmware on the systems to correct the defect and prevent recurrence.
3.You will provide progress reports on the effectiveness of the plan.
For further questions, please call (714) 730-5000.
Root Cause
Software design
Distribution Pattern
US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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