Device recall
Z-2297-2020: Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331…
FDA device recall · Class II · Elekta Limited
Key facts
| Recall number (Z-number) | Z-2297-2020 |
|---|---|
| Recall event | 85600 |
| Product | Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 |
| Product code | IYE |
| Recalling firm | Elekta Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2024 |
| 510(k) numbers | K192482 |
| FEI number | 3002806900 |
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