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FDAMarch 12, 2026device

ARTIS Pheno VE30A and VE40A, Model 10849000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

siemens medical solutionssiemenssiemens medical

UPCs

04056869046877

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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ARTIS Pheno VE30A and VE40A, Model 10849000 — Recall Details · AllClear