Reported Sep 6, 2017 · Terminated
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for…
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · PO Box 2068 · Tustin, CA · 92780-7047
Is this the product you have?
- Toshiba America Medical Systems Ultimax
- Digital Fluoroscopic X-Ray System ModelDREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications
- ranging from but not limited tocontrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography
- Lot codes and dates
- Ser. No. U1A1692606
- Amount recalled
- 18
Where it was sold
Why it was recalled
The issue was identified as a firmware problem with the generator.
This product could cause temporary or reversible health problems — stop using it.
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