Recall Z-2089-2015
Eizo Corporation · initiated July 7, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 220045044, 20050044
Reason for recall
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
FDA-determined cause: Device Design
Action taken
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, us.feedback@eizo.com, 5710 Warland Drive, Cypress, CA 90630).
Details
- Recall number
- Z-2089-2015
- Initiated
- July 7, 2015
- Posted by FDA
- July 16, 2015
- Terminated
- November 30, 2016
- Product code
- PGY – Display, Diagnostic Radiology
- Quantity
- 2 units
- Distribution
- Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
- Recalling firm
- Eizo Corporation
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2087-2015 Class II | RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5…EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular… | 07/07/2015Terminated |
| Z-2088-2015 Class II | RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC…EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular… | 07/07/2015Terminated |