Siemens ARTIS pheno and ARTIS Icono biplane systems recalled for inaccurate x-ray dose display
Siemens ARTIS pheno and ARTIS Icono biplane imaging systems may occasionally display an incorrect, higher x-ray dose reading during patient exams. The actual radiation dose delivered is safe and meets regulatory standards, but the displayed reading can be misleading. This affects certain model numbers used in hospitals and imaging centers.
From the FDA notice · Read the official notice ↗ · All Siemens recalls
What to do
- If you operate or manage one of these systems, contact Siemens Medical Solutions USA immediately for guidance
- Do not stop using the system; actual radiation levels are safe
- Ask Siemens for software or firmware updates to correct the dose display
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- U.S. 758, OUS 2077
- Illnesses reported
- None reported
- Manufactured in
- 40 Liberty Blvd, Malvern, PA, United States
- Classification
- Class II
- Recall number
- Z-1653-2026
In the FDA's words
- Description
- 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. ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325. Distribution: Worldwide - US Nationwide distribution. Affected quantity: U.S. 758, OUS 2077
- Hazard
- 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.
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ModerateFDANov 6, 2026