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Canon Medical System, USA, INC. recalls Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE,
Recalled March 24, 2021 · FDA recall Z-1271-2021 · Canon Medical System, USA
Hazard
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. · FDA Class II
Units
Total of all Systems = 145 systems (U.S.)
Sold at
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of Canada, China, Japan, Korea, and Singapore.
Description
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Product
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: 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 →