Medical device recalls Moderate risk

Eizo Corporation recalls RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological im…

Recall date
July 30, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2294-2020
FDA classification
Class II
Brand / firm
Eizo Corporation
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Massachusetts, Michigan, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Me…

Why it was recalled

Under certain conditions, a marble pattern infrequently appears on the monitor.

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

What was recalled

RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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