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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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 →Related recalls
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