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Medical Device

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Recall date: 2026-06-10 · Source: FDA_DEVICE
Brand / Firm
Siemens Medical Solutions USA, Inc
Product
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Reason for recall
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.
Description
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
View official recall notice →