Device recall
Z-2088-2015: RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC…
FDA device recall · Class II · Eizo Corporation
Key facts
| Recall number (Z-number) | Z-2088-2015 |
|---|---|
| Recall event | 71628 |
| Product | RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis. |
| Product code | PGY |
| Recalling firm | Eizo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2016 |
| 510(k) numbers | K134002 |
| 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