Health product recall

Leksell Gamma Knives

Last updated

Summary

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

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Elekta Solutions Ab
Hagaplan 4, Stockholm, Sweden, 11368
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81619

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