Recall Z-3070-2017— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2017-03-15, terminated 2020-09-25. It names one FDA 510(k) clearance: K170832. 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.. Reason: The issue was identified as a firmware problem with the generator..
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-15
- Terminated
- 2020-09-25
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.