Leksell Gamma Knives

Leksell Gamma Knife Recall Summary Leksell Gamma Knives used for radiation therapy are being recalled in Canada due to a performance issue. This recall affects all Leksell Gamma Knife devices distributed across Canada. The FDA has classified this as a Class I recall, the most serious category.

Product

Leksell Gamma Knives

Reason

Device performance issue

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-02-18

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/348f5fa4-da89-4474-a568-41d6e3449102