CLASS II ONGOING Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

RadiForce RX360 recalled by Eizo

Eizo is recalling RadiForce RX360, distributed nationwide in the US. The recall was initiated on 30 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.

Quantity recalled1,466 monitors dist. to the U.S.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2294-2020
FDA event ID: 85299
Recalling firm: Eizo, Hakusan, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jul 2019
FDA classified: 8 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

30 Jul 2019	Recall initiated by company
8 Jun 2020	Classified by FDA	+314 days
17 Jun 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was 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 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.

Nationwide Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Illinois Indiana Kansas Louisiana Massachusetts Maine Michigan Missouri Montana North Carolina New Hampshire

Questions about this recall

Is RadiForce RX360 recalled?

Yes. Eizo recalled RadiForce RX360 on 30 Jul 2019. The recall is Class II and its status is Ongoing. Recall number Z-2294-2020.

Why was it recalled?

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

Which lots are affected?

RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Eizo

All 5

Reported	Class	Recall	Company	Reason	Where
17 Jun 2020Device	CLASS II	RadiForce GX560 monochrome LCD monitor recalled by Eizo	Eizo	Other	Nationwide
22 Jul 2015Device	CLASS II	RadiForce RX850, 8MP Color LCD Monitor, Part recalled by Eizo	Eizo	Other	Nationwide
22 Jul 2015Device	CLASS II	RadiForce RX650, 6MP Color LCD Monitor, Part recalled by Eizo	Eizo	Device Malfunction	Nationwide
22 Jul 2015Device	CLASS II	RadiForce GX540, 5MP Monochrome LCD Monitor, Part recalled by Eizo	Eizo	Other	Nationwide

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