Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006
- 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:
- Canon Medical System, USA, INC.
- Reason for Recall:
- Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Product Codes/Lot Numbers:
Serial Numbers: AGB1692005, AGB17Z2010, AGA1552003, AGB17Y2009, AGB1682004, AGA1492002, AGC1822012, A5C1922001, AGB1712007, AGC1952014, AGB1482001, AGC1822011, BGB1992001, AGC18X2013, AGB16Z2006
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2327-2020
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