fda_recall · device_recall · high

Siemens Medical Solutions USA, Inc — Class II recall: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000,…

Event date
2026-04-15 00:00:00Z
Observed
2026-07-09 22:53:06Z
Source ID
Z-1653-2026
Payload hash
a6f62e01208955aee5ef8c82

Summary

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… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.