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Canon Medical System, USA, INC. recalls Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluo
Recalled June 17, 2020 · FDA recall Z-2327-2020 · Canon Medical System, USA
Hazard
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. · FDA Class II
Units
15
Sold at
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.
Description
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
Product
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.
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →