RadiForce recallZ-2294-2020 · Eizo Corporation · initiated Jul 30, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Eizo Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Under certain conditions, a marble pattern infrequently appears on the monitor.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2294-2020
- Status
- Open, Classified
- Initiated by the company
- Jul 30, 2019
- Recalling firm
- Eizo Corporation
- Quantity
- 1,466 monitors dist. to the U.S.
- Product code
- PGY
- FDA submissions
- K182591
- Distribution
- 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.
Product description
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.
Code information (models, lots, serial numbers)
RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- RadiForce® RX360Eizo Corporation · Display, Diagnostic Radiology1 recall0 reports
- RadiForce® RX360Eizo Corporation · Display, Diagnostic Radiology1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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