FDA-Device2019-11-20Class II
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
Canon Medical System, USA, INC.
Hazard
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.
Affected count
9 systems
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Products
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2020Don't want to check this manually?
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