RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
FDA Recall Z-2087-2015 · Posted 2015-07-16
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Recalling FirmEizo Corporation
Recall StatusTerminated
Product CodePGY
Date Initiated2015-07-07
Date Terminated2016-11-30
Product Quantity19 units
Reason for Recall
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
Firm Action
EIZO sent An Urgent Field Safety Notice dated July 7, 2015, to all customers who purchased the RadiForce RX440, RX650, RX850 and GX540. The notice informs customers that the RadiForce monitors could display abornormally in 6-bit (64 gradations) instead of normal 8-bit (256 gradations) or 10-bit (1024 gradations) while connecting to particular graphics boards with DisplayPort. The notice provides the customers with the actions to be taken and contact information (1-800-800-5202, M-F, 8am-4pm, PST, [email protected], 5710 Warland Drive, Cypress, CA 90630).
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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