Z-2294-2020Class II

RadiForce RX360, model 0FTD2346 -

Name: Z-2294-2020 RadiForce RX360, model 0FTD2346 -
Creator: Eizo Corporation
Published: 2019-07-30
License: https://open.fda.gov/license/

Eizo Corporation / initiated 2019-07-30 / Open, Classified / root cause: design

FDA source

Eizo Corporation began a recall of RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis... on 2019-07-30. FDA classified it as Class II and gives the reason as "Under certain conditions, a marble pattern infrequently appears on the monitor". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2294-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-07-30
Posted: 2020-06-08
Recalling firm: Eizo Corporation
Product: 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.
Product code: PGY Display, Diagnostic Radiology
Reason for recall: Under certain conditions, a marble pattern infrequently appears on the monitor.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1,466 monitors dist. to the U.S.
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 codes and lots: RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2294-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2293-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-08
Z-2294-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-08

Product code PGY

K182591Class IIRadiForce RX360, RX360-AREizo Corporation / cleared 2018-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)