Device recall
Z-0840-2020: Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA device recall · Class II · Palodex Group Oy
Key facts
| Recall number (Z-number) | Z-0840-2020 |
|---|---|
| Recall event | 84544 |
| Product | Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) |
| Product code | MQB |
| Recalling firm | Palodex Group Oy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2024 |
| 510(k) numbers | K041050 |
| FEI number | 3005383085 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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