Canon Medical System, USA, INC. recalls Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/flu…

Recall date

March 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2327-2020

FDA classification

Class II

Brand / firm

Canon Medical System, USA, INC.

Sold / distributed

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.

Why it was recalled

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.