Recall Z-2088-2015 ยท PGY Display, Diagnostic Radiology
Eizo Corporation
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
| Date | Jul 16, 2015 (initiated Jul 7, 2015) |
| Status | Terminated |
| Reason | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. |
| Root cause | Device Design |
| 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, us.feedback@eizo.com, 5710 Warland Drive, Cypress, CA 90630). |
| Quantity | 3 units |
| Distribution | Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K134002 | 6MP COLOR LCD MONITOR, RADIFORCE RX650 Eizo Corporation, Jan 31, 2014 |