Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD S…

Recall date

December 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1164-2026

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide

Why it was recalled

Due to a manufacturing issue and electrical grounding of systems.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No