Siemens Medical Solutions USA, Inc recalls ARTIS Pheno VE30A and VE40A, Model 10849000

Recall date

March 12, 2026

Source

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

Recall number

Z-1814-2026

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

U.S. and O.U.S.

Why it was recalled

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

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 Pheno VE30A and VE40A, Model 10849000