United StatesARTIS Pheno VE30A and VE40A, Model 10849000 (UDI 04056869046877) imaging systems are affected. During 3D acquisitions they can capture lighter and darker patient images leading to less accurate 3D reconstruction and, because of a constant unregulated medium dose combined with angular change of patient diameter, may result in unintentional low‑dose radiation exposure to a patient.
What's being recalled
ARTIS Pheno VE30A and VE40A, Model 10849000
Recalling firm: Siemens Medical Solutions USA, Inc, Malvern, PA, United States.
How to identify it
UDI 04056869046877
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. and O.U.S.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)