SIEMENS MEDICAL SOLUTIONS USA, INC recalls ARTIS One Angiographic X-Ray System

Recall date

January 2, 2025

Source

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

Recall number

Z-0922-2025

FDA classification

Class II

Brand / firm

SIEMENS MEDICAL SOLUTIONS USA, INC

Sold / distributed

23 Distributed in the US

Why it was recalled

A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.

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

What was recalled

ARTIS One Angiographic X-Ray System