ARTIS pheno and ARTIS Icono Biplane X-ray System
Siemens is recalling ARTIS pheno and ARTIS Icono X-ray systems (Models 10849000, 11327600, 11328100, 11327700) due to erroneous dose display during patient exams.
Contact Siemens Medical Solutions USA, Inc. for instructions on a software update or corrective action to address the dose display issue.
Why it was recalled
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.
How to identify it
UPC 4056869046877 4056869063317 4056869295923 4056869149325
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Where it was sold
Distributed in US.
Official source
Other recent recalls from Siemens Medical Solutions USA, Inc
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification