FDAClass II · Medical device · Recalled June 10, 2026
ARTIS pheno recall — Siemens Medical Solutions USA, Inc
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
Description
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.