Recall Z-3070-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Toshiba American Medical Systems Inc
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 contras
| Date | Mar 15, 2017 |
| Status | Terminated |
| Reason | The issue was identified as a firmware problem with the generator. |
| Root cause | Software design |
| 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. |
| Quantity | 18 |
| Distribution | US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170832 | Ultimax-i, DREX-UI80 V1.60 Toshibamedical Systems Corporation, Jul 21, 2017 |