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Medical Device

ARTIS Pheno VE30A and VE40A, Model 10849000

Recall date: 2026-04-22 · Source: FDA_DEVICE
Product
ARTIS Pheno VE30A and VE40A, Model 10849000
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.
Units affected
73
Description
ARTIS Pheno VE30A and VE40A, Model 10849000
View official recall notice →