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.
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