Device recall
Z-0433-2026: Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage…
FDA device recall · Class II · Elekta, Inc.
Key facts
| Recall number (Z-number) | Z-0433-2026 |
|---|---|
| Recall event | 97705 |
| Product | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform… |
| Product code | HAW |
| Recalling firm | Elekta, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190887 |
| FEI number | 1037831 |
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