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Siemens ARTIS pheno X-Ray System
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MEDICAL DEVICE RECALLMODERATE

Siemens ARTIS pheno X-Ray System

Siemens is recalling the ARTIS pheno x-ray system (Model 10849000) because it may incorrectly display an x-ray dose of zero during use.

What to do

Contact your Siemens service representative to schedule a software update to resolve the display error. Continue to monitor patient dose using alternative methods until the update is installed.

Posted
Updated
Agency
Firm
Siemens Medical Solutions USA, Inc
Recall ID
98992
Status
ONGOING

Why it was recalled

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.

How to identify it

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

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification