Drug recall
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon"…
FDA recall event 98443 · Class II · Elekta, Inc.
Key facts
| Event ID | 98443 |
|---|---|
| Recall numbers | Z-1581-2026 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to adapter not being properly aligned or locked in place. |
| Initiation date | Feb 18, 2026 |
| Report date | Mar 25, 2026 |
| 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: