Device recall
Z-2293-2020: RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product…
FDA device recall · Class II · Eizo Corporation
Key facts
| Recall number (Z-number) | Z-2293-2020 |
|---|---|
| Recall event | 85299 |
| Product | 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. |
| Product code | PGY |
| Recalling firm | Eizo Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K181609 |
| FEI number | 3000237660 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database