Siemens Medical Solutions USA, Inc recalls ARTIS Icono biplane
- Recalling company
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 9, 2026
- Reported
- Jun 10, 2026
- Distribution
- US and Worldwide
- Status
- Ongoing
- Lot / codes
- 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-2206-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2206-2026 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.