The Recall Desk
HighFDA (Devices)·Z-2089-2015·Announced 2015-07-22

Eizo RadiForce RX850 Medical Monitors Recalled for Display Abnormalities

Eizo is recalling RadiForce RX850 medical monitors because they may display images abnormally when connected to specific graphics boards using DisplayPort.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for diagnostic imaging (mammography) where display abnormalities could lead to misdiagnosis or missed diagnoses, representing a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Eizo Corporation is recalling the RadiForce RX850, 8MP Color LCD Monitor (Part Code No. 0FTD1958A2, UPC 690592037180). This product is intended for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

The recall was initiated because the monitors could display abnormally while connecting to particular graphics boards with DisplayPort. The source text does not specify the exact nature of the display abnormalities or the specific graphics boards involved.

A total of 2 units were distributed nationwide, including to Ohio, Florida, Illinois, Texas, New York, Arizona, and New Jersey. The source text does not provide specific instructions for consumers or medical facilities on how to resolve the issue, such as returning the product or seeking a replacement.

The recalled product

Product
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
Manufacturer
Eizo Corporation
Category
Medical Device — Diagnostic Imaging Monitor
Hazard
Affected units
2

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 (2)

  • 220045044
  • 20050044

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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