Open, Classified

RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

FDA Recall Z-2293-2020 · Posted None

Recalling FirmEizo Corporation

Recall StatusOpen, Classified

Product CodePGY

Date Initiated2019-07-30

Product Quantity96 monitors dist. to the U.S.

Reason for Recall

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

Firm Action

EIZO Japan announced the recall on their website on 7/30/2019. EIZO U.S. began contacting their consignees via email and phone (one as early as 8/7/2019, some on 10/18/2019, but the majority on 11/26/2019) and began updating consignee monitors with the firmware. The notification requested the consignee contact EIZO U.S. for assistance with the firmware update.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181609RadiForce GX560, GX560-AREizo Corporation · 2018-08-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.