Recall Z-2293-2020— Eizo Corporation
Class II · Ongoing
Class II FDA medical device recall by Eizo Corporation, initiated 2019-07-30. It names one FDA 510(k) clearance: K181609. Product: RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.. Reason: Under certain conditions, a marble pattern infrequently appears on the monitor..
- Recalling firm
- Eizo Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-07-30
- Firm location
- Hakusan, N/A, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Reason for recall
Under certain conditions, a marble pattern infrequently appears on the monitor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.