Recall Z-1581-2026— Elekta, Inc.

Name: FDA recall Z-1581-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-18

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2026-02-18. It names one FDA 510(k) clearance: K250391. 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 structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.. Reason: Due to adapter not being properly aligned or locked in place..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-18
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K250391 — Leksell Gamma Knife® (3 models)Elekta Solutions AB·cleared 2025-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Due to adapter not being properly aligned or locked in place.

Data sourced from openFDA. This site is unofficial and independent of the FDA.