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
Siemens Medical Solutions is recalling ARTIS pheno and ARTIS Icono biplane X-ray systems (Model Numbers 10849000, 11327600, 11328100, 11327700) because the system may sporadically display an incorrect major increase in reported x-ray dose to the patient during examinations, potentially causing confusion about radiation exposure despite actual dose levels being compliant with regulatory requirements.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- UPC
- 4056869046877, 4056869063317, 4056869295923, 4056869149325
- Recall #
- Z-1653-2026
Where it was sold
Distributed nationwide.
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