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

Medical DevicesSource: FDA (device) · Date: 2026-04-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Medical Solutions USA, Inc
Product
ARTIS Pheno VE30A and VE40A, Model 10849000
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. and O.U.S.
Recall initiated
2026-03-12
Code info
UDI 04056869046877
Product quantity
73
Voluntary mandated
FDA Mandated
City
Malvern
State
PA
Country
United States
Event id
98772
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