FDA DeviceClass IINotable

FDA Recall: Brand Name: Leksell Vantage Arc System REF: 1053958

Date: 2026-05-06
Brand: Elekta, Inc.
Category: Medical Device
FDA Class: Class II

Description

Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

Hazard

Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

Remedy

768 (364Left/364Right)

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