Recall
FDAHealthMarch 12, 2026

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

⚠️ 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.

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
March 12, 2026

U.S. and O.U.S.

What's affected?

Product
ARTIS Pheno VE30A and VE40A, Model 10849000
Lot code
UDI 04056869046877

Additional details

UDI 04056869046877

What should I do?

Recommended action

Class II recall. FDA Mandated Quantity affected: 73.

View original FDA notice →

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