CanadaThe recall affects Leksell Gamma Knife devices (Perfexion, Icon) and Leksell Gamma Knife Elekta Esprit, identifiable by model/catalogue numbers 715000, 1016200, and 1110200 (all lots/serial numbers). It was recalled because a QA procedure was started while the adapter was not properly locked to the patient positioning system, causing the QA check to fail. Elekta will issue a Field Safety Notice on 18 Feb 2026 and update the instructions for use (IFU) to include a new warning.
What's being recalled
Companies: Elekta Solutions Ab, Hagaplan 4, Stockholm, Sweden, 11368.
How to identify it
Affected products: Leksell Gamma Knife® Perfexion™; Lot or serial number: All lots.; Model or catalogue number: 715000
Affected products: Leksell Gamma Knife® Icon™; Lot or serial number: All lots.; Model or catalogue number: 1016200
Affected products: Leksell Gamma Knife® Elekta Esprit™; Lot or serial number: All lots.; Model or catalogue number: 1110200
The hazard
When treating patients with the Leksell Gamma Knife®, the patient is attached to the device via an adapter. The adapter is the interface between the Leksell Gamma Knife® and the immobilization system used for the treatment. The Leksell Gamma Knife® has three types of adapters for patient fixation, the g-frame adapter, the vantage adapter, and the mask adapter. Elekta has become aware that a Quality Assurance (QA) procedure was initiated while the adapter was not properly locked to the patient positioning system of the Leksell Gamma Knife® as a result, the QA check failed.
What to do
Elekta will issue a Field Safety Notice on 18 Feb 2026 for affected Gamme Knife and Elekta Esprit devices. The IFU will be updated to include a new warning.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States