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Elekta Solutions AbmedicalMedium PriorityActive

Leksell Gamma Knives Recall

Health Canada recall RA-81619: During treatment with Leksell Gamma Knife systems, a Quality Assurance procedure was initiated while the adapter was not properly locked to the patient positioning system, causing the QA check to fail. Health Canada lists this as a Type II health product recall for affected Leksell Gamma Knife Perfexion, Icon, and Elekta Esprit devices.

By RecallRadar Editorial Team

Sourced from Health Canada. Last verified March 4, 2026.

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Key facts

Date announced
February 18, 2026
Source agency
Health Canada

This recall affects device functionality. Consider taking action soon.

✨ Plain-English Summary

Health Canada issued recall RA-81619 for Leksell Gamma Knife Perfexion, Icon, and Elekta Esprit systems. The notice is a Type II health product recall involving a QA procedure started while the adapter was not properly locked to the patient positioning system; Elekta is issuing a Field Safety Notice and IFU warning update.

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Full details from the recall report.

Health Canada recall RA-81619: During treatment with Leksell Gamma Knife systems, a Quality Assurance procedure was initiated while the adapter was not properly locked to the patient positioning system, causing the QA check to fail. Health Canada lists this as a Type II health product recall for affected Leksell Gamma Knife Perfexion, Icon, and Elekta Esprit devices.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand
Elekta solutions ab
Category
medical
Source agency
Health Canada
Announced
February 18, 2026
Country
CA
Status
Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Leksell Gamma Knife® Elekta Esprit™ — all lots — model 1110200

Model #2

Leksell Gamma Knife® Icon™ — all lots — model 1016200

Model #3

Leksell Gamma Knife® Perfexion™ — all lots — model 715000

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

  1. 1Healthcare facilities using affected Leksell Gamma Knife Perfexion, Icon, or Elekta Esprit systems should review Elekta's Field Safety Notice.
  2. 2Confirm whether all lots/model numbers listed in the Health Canada notice are present at the facility.
  3. 3Follow the updated Instructions for Use warning and Elekta's official remedy instructions.
Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source
Health Canada
Announced by source
February 18, 2026
Last reviewed by RecallRadar
March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Leksell Gamma Knife® Elekta Esprit™ — all lots — model 1110200, Leksell Gamma Knife® Icon™ — all lots — model 1016200, Leksell Gamma Knife® Perfexion™ — all lots — model 715000.

What is the remedy for this recall?

1. Healthcare facilities using affected Leksell Gamma Knife Perfexion, Icon, or Elekta Esprit systems should review Elekta's Field Safety Notice. 2. Confirm whether all lots/model numbers listed in the Health Canada notice are present at the facility. 3. Follow the updated Instructions for Use warning and Elekta's official remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://recalls-rappels.canada.ca/en/alert-recall/leksell-gamma-knives

Keep browsing with these internal hubs: Elekta Solutions Ab recall hub and Medical recall hub.

Official Resources

Use these primary sources for final eligibility and claim instructions.

View official notice from Health Canada

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