Recalling firm
Siemens Medical Solutions USA, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-22
Distribution
U.S. and O.U.S.
Firm state
PA
Product quantity
73
Initiated by
FDA Mandated
Reason for recall
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.
Product description
ARTIS Pheno VE30A and VE40A, Model 10849000
Code / lot info
UDI 04056869046877
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.