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Siemens Medical Solutions USA, Inc: ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

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

Read the official notice at FDA (device) →

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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, Model 10849000. 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
UDI: 4056869046877
Voluntary mandated
FDA Mandated
City
Malvern
State
PA
Country
United States
Event id
98992
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