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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Ser. No. U1A1692606
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Toshiba American Medical Systems Inc
- Reason for Recall:
- The issue was identified as a firmware problem with the generator.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Ser. No. U1A1692606
Distribution:
Distributed in: US, LA, AR, IA, TX, IL, MN, MS, NJ, WV, SC, WY, NC, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3070-2017
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