Z-3070-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- March 15, 2017
- Termination Date
- September 25, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 18
Product Description
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.
Reason for Recall
The issue was identified as a firmware problem with the generator.
Distribution Pattern
US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
Code Information
Ser. No. U1A1692606