The Recall Desk
ModerateFDA (Devices)·Z-2294-2020·Announced 2020-06-17

Eizo RadiForce RX360 Medical Monitor Recalled for Display Defect

Eizo Corporation is recalling 1,466 RadiForce RX360 medical monitors because a marble pattern may infrequently appear on the display under certain conditions.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score. The defect is a visual display issue (marble pattern) that is infrequent and does not involve reported injuries or high-risk pathogens.

Plain-English summary

Eizo Corporation is recalling the RadiForce RX360, model 0FTD2346, 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. The recall involves 1,466 monitors distributed to the United States.

The recall was initiated because, under certain conditions, a marble pattern infrequently appears on the monitor. The affected units are identified by software version 1.0001 or earlier and UDI codes 04995047053279 or 04995047053293.

Distribution was worldwide, including nationwide distribution in the United States to specific states and Puerto Rico, as well as to numerous international countries. There were no government or military consignees. Consumers and medical practitioners should contact Eizo Corporation for further instructions regarding the recall.

The recalled product

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.
Manufacturer
Eizo Corporation
Affected units
1,466

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Eizo Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →