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.
This recall has been terminated (originally issued March 15, 2017).
- Recall Initiated
- March 15, 2017
- Terminated
- September 25, 2020
- Recall Number
- Z-3070-2017
- Quantity
- 18
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Ser. No. U1A1692606
Root Cause
Software design
Action Taken
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.