Leksell Vantage stereotactic system safety information

ANSM Drug & Device Safety Alerts

Published March 17th, 2026

Detected March 17th, 2026

Summary

The French ANSM has issued a safety notice regarding the Leksell Vantage stereotactic system by Elekta Ltd. This action, registered under number R2607991, is based on a safety action implemented by the manufacturer. Affected healthcare facilities have been notified.

View original document View source feed page

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety information notice concerning the Leksell Vantage stereotactic system manufactured by Elekta Ltd. The notice, registered under number R2607991, highlights a safety action undertaken by the manufacturer, with details provided in a letter dated March 17, 2026, sent directly to affected healthcare facilities.

Healthcare providers utilizing the Leksell Vantage system should review the safety information and the manufacturer's communication. Any questions should be directed to Elekta Ltd. This notice serves as an alert to potential safety concerns and requires awareness from relevant medical professionals and institutions to ensure patient safety and proper device management.

What to do next

Review safety information regarding the Leksell Vantage stereotactic system.
Consult the manufacturer's communication for specific instructions.
Direct any questions to Elekta Ltd.

Source document (simplified)

A+ A-

Information n° R2607991 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Elekta Ltd.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607991.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Elekta Ltd (17/03/2026)