Recall MonitorHealth Products
Leksell Gamma Knives
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Leksell Gamma Knives
Issue: Medical devices - Performance
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.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Leksell Gamma Knife® Perfexion™ | All lots. | 715000 |
| Leksell Gamma Knife® Icon™ | All lots. | 1016200 |
| Leksell Gamma Knife® Elekta Esprit™ | All lots. | 1110200 |
Issue
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.