Siemens Medical Solutions USA, Inc recalls ARTIS pheno and ARTIS Icono biplane
- Recalling company
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 10, 2026
- Reported
- Apr 15, 2026
- Distribution
- Worldwide - US Nationwide distribution.
- Status
- Ongoing
- Quantity
- U.S. 758, OUS 2077
- Lot / codes
- ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
- Company location
- Malvern, PA
- Recall type
- FDA Mandated
- Recall number
- Z-1653-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1653-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.