Medical device recalls Moderate risk

Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958

Recall date
March 19, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2006-2026
FDA classification
Class II
Brand / firm
Elekta, Inc.
Sold / distributed
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Why it was recalled

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

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: Leksell Vantage Arc System REF: 1053958

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