Reported Apr 15, 2026 · Ongoing
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
ARTIS pheno and ARTIS Icono biplanefloor and ceiling. Model Numbers 10849000113276001132810011327700
- Lot codes and dates
- ARTIS pheno UDI4056869046877
- ARTIS icono biplane UDI4056869063317
- ARTIS icono ceiling UDI4056869295923
- ARTIS icono floor UDI4056869149325
- Amount recalled
- U.S. 758, OUS 2077
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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