Siemens Medical Solutions USA, Inc recalls MAMMOMAT Fusion;

Recall date

October 24, 2025

Source

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

Recall number

Z-0879-2026

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.

Why it was recalled

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

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

What was recalled

MAMMOMAT Fusion;