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ARTIS pheno Interventional Fluoroscopic X-ray System
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MEDICAL DEVICE RECALLMODERATE

ARTIS pheno Interventional Fluoroscopic X-ray System

Siemens recalls ARTIS pheno x-ray system, Model 10849000, due to dose display error during exams.

What to do

Contact Siemens Medical Solutions for instructions on system correction and continued safe use.

Posted
Updated
Recall No.
Z-2205-2026
Agency
Firm
Siemens Medical Solutions USA, Inc
Recall ID
98992
Status
ONGOING

Why it was recalled

Siemens Medical Solutions is recalling the ARTIS pheno interventional fluoroscopic x-ray system, Model 10849000, because during patient examinations the system may sporadically display a 0 x-ray dose administered to the patient while an actual x-ray dose is applied. This behavior has been observed during fluoroscopy and/or single-frame acquisitions.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUPCRecall #
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 system4056869063317, 4056869295923, 4056869149325Z-2206-2026
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system4056869046877Z-2205-2026

Other recent recalls from Siemens Medical Solutions USA, Inc

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification