Siemens Medical Solutions USA, Inc — ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
⚠️ During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 10, 2026
Worldwide - US Nationwide distribution.
What's affected?
- Product
- ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Lot code
- ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
Additional details
ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
What should I do?
Recommended action
Class II recall. FDA Mandated Quantity affected: U.S. 758, OUS 2077.
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