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Siemens Medical Solutions USA, Inc: ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 113

Medical DevicesSource: FDA (device) · Date: 2026-06-10

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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 Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Reason / hazard
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Classification
Class II
Status
Ongoing
Distribution / sold at
US and Worldwide
Recall initiated
2026-03-09
Code info
ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
Voluntary mandated
FDA Mandated
City
Malvern
State
PA
Country
United States
Event id
98992
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