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Siemens Medical Solutions USA, Inc: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

Medical DevicesSource: FDA (device) · Date: 2026-04-15

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Medical Solutions USA, Inc
Product
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-03-10
Code info
ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
Product quantity
U.S. 758, OUS 2077
Voluntary mandated
FDA Mandated
City
Malvern
State
PA
Country
United States
Event id
98675
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