FDA-Device2021-03-24Class II
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V 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.
Canon Medical System, USA, INC.
Hazard
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Sold states
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.
Affected count
Total of all Systems = 145 systems (U.S.)
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2021Don't want to check this manually?
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