United StatesARTIS pheno and ARTIS Icono biplane imaging systems (floor and ceiling versions; model numbers 10849000, 11327600, 11328100, 11327700; UDIs 4056869046877, 4056869063317, 4056869295923, 4056869149325) are affected. They were recalled because the system may sporadically display a major increase of the x‑ray dose during patient examinations, although the actual applied x‑ray dose remains in accordance with the system settings and applicable regulatory requirements.
What's being recalled
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Recalling firm: Siemens Medical Solutions USA, Inc, Malvern, PA, United States.
How to identify it
ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
The hazard
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
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
Worldwide - US Nationwide distribution.
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)