Warning
Siemens Medical Solutions USA Recalls ARTIS Pheno VE30A and VE40A
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1814-2026Medical Device
Siemens Medical Solutions USA Recalls ARTIS Pheno VE30A and VE40A
Siemens Medical Solutions USA, Inc · Class II — Moderate Risk
Product Description
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. and O.U.S.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database