Medical device recalls Moderate risk

Canon Medical System, USA, INC. recalls Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is use…

Recall date
February 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0360-2020
FDA classification
Class II
Brand / firm
Canon Medical System, USA, INC.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.

Why it was recalled

Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.

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 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.

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