Infinix-8000V 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: A5B1642006, A1B17X2004, A5A1612005, A5B1772009, B5B1962002, A3A1522004, A7B16Y2001, A3A1712011, A5B1792010, A5A1532002, A1A1612003, A3A15Z2007, A5A1552003, A5B16Y2007, A3B1862016, A3B1812013, A3A1662009, A9A16X2004, BTA1922001, A3B1842015, AOB1882001, BMB1942001, AOB1892002, A5B1472001, A5B17Z2011, A3A14X2002, A5A1592004, A3A17Z2012, A5C1832012, A5B16Z2008, A1A1582002, A9A1582002, A1A14X2001, A3A1512003, A7C1812002, ABC18X2002, A3A1592005, UTC14Y2008, A3A15X2006, B5B1942001, A3A1682010, A1C18Z2005, A9A1662003, A3A1492001, A3B1822014, A3A1622008
- 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-8000V 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: A5B1642006, A1B17X2004, A5A1612005, A5B1772009, B5B1962002, A3A1522004, A7B16Y2001, A3A1712011, A5B1792010, A5A1532002, A1A1612003, A3A15Z2007, A5A1552003, A5B16Y2007, A3B1862016, A3B1812013, A3A1662009, A9A16X2004, BTA1922001, A3B1842015, AOB1882001, BMB1942001, AOB1892002, A5B1472001, A5B17Z2011, A3A14X2002, A5A1592004, A3A17Z2012, A5C1832012, A5B16Z2008, A1A1582002, A9A1582002, A1A14X2001, A3A1512003, A7C1812002, ABC18X2002, A3A1592005, UTC14Y2008, A3A15X2006, B5B1942001, A3A1682010, A1C18Z2005, A9A1662003, A3A1492001, A3B1822014, A3A1622008
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2325-2020
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