Drug recall
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version…
FDA recall event 97705 · Class II · Elekta, Inc.
Key facts
| Event ID | 97705 |
|---|---|
| Recall numbers | Z-0433-2026 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound |
| Initiation date | Sep 30, 2025 |
| Report date | Nov 12, 2025 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 1037831 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: