FDA DeviceClass IINotable

FDA Recall: Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma

Date: 2026-03-25
Brand: Elekta, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to adapter not being properly aligned or locked in place.

Hazard

Due to adapter not being properly aligned or locked in place.

Remedy

352

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