Device recall
Z-1581-2026: Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-1581-2026 |
|---|---|
| Recall event | 98443 |
| Product | Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon" Leksell Gamma Knife Elekta Esprit Leksell Gamma Knife (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head… |
| Product code | IWB |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K250391 |
| FEI number | 1037831 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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