Recall Z-2294-2020 ยท PGY Display, Diagnostic Radiology
Eizo Corporation
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
| 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 | 1,466 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
| K182591 | RadiForce RX360, RX360-AR Eizo Corporation, Oct 18, 2018 |