Device recall
Z-2089-2015: RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC…
FDA device recall · Class II · Eizo Corporation
Key facts
| Recall number (Z-number) | Z-2089-2015 |
|---|---|
| Recall event | 71628 |
| Product | 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. |
| Product code | PGY |
| Recalling firm | Eizo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2016 |
| 510(k) numbers | K140702 |
| 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