FDA-Device2026-04-15Class II

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Siemens Medical Solutions USA, Inc

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.

Sold states

Worldwide - US Nationwide distribution.

Affected count

U.S. 758, OUS 2077

Manufactured in

40 Liberty Blvd, Malvern, PA, United States

Products

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2026

Original summary

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. 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. ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325. Distribution: Worldwide - US Nationwide distribution. Affected quantity: U.S. 758, OUS 2077

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