United StatesSiemens ARTIS pheno (Model 10849000) and ARTIS icono interventional fluoroscopic x‑ray systems (biplane Model 11327600, ceiling Model 11328100, floor Model 11327700; UDIs listed) are affected. During fluoroscopy and/or single‑frame acquisitions the systems may sporadically display a 0 x‑ray dose administered even though an actual x‑ray dose is applied to the patient.
What's being recalled
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Recalling firm: Siemens Medical Solutions USA, Inc, Malvern, PA, United States.
How to identify it
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 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the 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
US and Worldwide
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)