Leksell Gamma Knives
Brand(s)
Summary
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.
Affected 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.
Additional information
Details
| Elekta Solutions Ab |
| Hagaplan 4, Stockholm, Sweden, 11368 |
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