Leksell Gamma Knife Radiosurgery System
Elekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit systems due to potential adapter misalignment during radiation delivery.
Contact your Elekta service representative to schedule an inspection and ensure the adapter is correctly aligned and locked.
Why it was recalled
Elekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit radiosurgery systems due to a risk that the adapter may not be properly aligned or locked in place. This issue could lead to inaccurate radiation delivery during stereotactic irradiation procedures. The recall is distributed nationwide.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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 structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
- UPC
- 07340048303019, 30002718, 30002934, 30000655, 30001910, 30000732, 30001270, 30001527
- Recall #
- Z-1581-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Elekta, Inc.
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification