FDA-Device2026-04-22Class II
ARTIS Pheno VE30A and VE40A, Model 10849000
Siemens Medical Solutions USA, Inc
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.
Sold states
U.S. and O.U.S.
Affected count
73
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTIS Pheno VE30A and VE40A, Model 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1814-2026Original summary
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. UDI 04056869046877 Distribution: U.S. and O.U.S. Affected quantity: 73
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