Canon Medical System, USA, INC. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Canon Medical System, USA, INC.
Lot Codes / Batch 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
Products Sold
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
Canon Medical System, USA, INC. is recalling Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digi due to Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Recommended Action
Per FDA guidance
On 03/03/20, Urgent Medical Device Correction notices were mailed to Radiology Managers/Directors. To correct this issue, the bolts holding the longitudinal movement of the table will need to be inspected to determine if the bolts are tightened to specification. Recalling firm service representatives will contact customers to set up appointments to inspect bolts. Radiology Managers/Directors were advised of the following: a) Should this problem occur before your appointment with the recalling firm's service representative, please stop using the system and contact the service representative. b) If abnormalities are found operating the table during a procedure, please stop use, and contact the service representative. c) Share this information with all users and reviewing radiologists as well as clinical engineering, and the biomedical group at your facility. d) Complete and return the Customer Reply Form. Additional questions should be directed to (800) 421-1968 or your local service representative (800) 521-1968
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026