Recall Z-2293-2020 ยท PGY Display, Diagnostic Radiology
Eizo Corporation
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.
| Date | Jul 30, 2019 |
| Status | Open, Classified |
| Reason | Under certain conditions, a marble pattern infrequently appears on the monitor. |
| Root cause | Device Design |
| Action | EIZO Japan announced the recall on their website on 7/30/2019. EIZO U.S. began contacting their consignees via email and phone (one as early as 8/7/2019, some on 10/18/2019, but the majority on 11/26/2019) and began updating consignee monitors with the firmware. The notification requested the consignee contact EIZO U.S. for assistance with the firmware update. |
| Quantity | 96 monitors dist. to the U.S. |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Massachusetts, Michigan, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Me |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181609 | RadiForce GX560, GX560-AR Eizo Corporation, Aug 24, 2018 |