FDA-Device2020-06-17Class II
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.
Canon Medical System, USA, INC.
Hazard
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Sold states
US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.
Affected count
46
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2020Don't want to check this manually?
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