Infinix-8000C 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: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001
- 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-8000C 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: B8B1972001, A9A1592001, A3A14Z2001, AEB1812002, A1B1552001, A9C18Y2007, A3E1922002, B5B1952001, A9C1822006, A9B1622002, A9B1722003, A5C1622001, B3B19Y2001, A1D1772003, B1B19X2001, A5C16Y2002, A9C1822005, A1E1862008, A1D1752002, A1E1832004, A1E1852005, A1E1852006, A5E1862003, AEA17X2001
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2326-2020
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