Recall Z-2089-2015 ยท PGY Display, Diagnostic Radiology
Eizo Corporation
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.
| 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 | 2 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
| K140702 | 8MP COLOR LCD MONITOR, RADIFORCE RX850 Eizo Corporation, Apr 4, 2014 |