FDA-Device2020-06-17Class II

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.

Eizo Corporation
Hazard

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

Sold states
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 Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin. Distribution was also made to Puerto Rico. There was no government/military consignees. The countries of Canada, Australia, Austria, Belgium, Brazil, China, Czech Republic, Egypt, France, Germany Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Netherlands, Pakistan, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Affected count
1,466 monitors dist. to the U.S.
Manufactured in
Eizo ( Kabu ), N/A, Hakusan, N/A, Japan
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2294-2020

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