FDAHealthMarch 9, 2026
Siemens Medical Solutions USA, Inc — ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
⚠️ 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- March 9, 2026
US and Worldwide
What's affected?
- Product
- ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- Lot code
- UDI: 4056869046877
Additional details
UDI: 4056869046877
What should I do?
Recommended action
Class II recall. FDA Mandated
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