FDAFDA · Food and drugs·Recall number Z-2206-2026
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
Published June 10, 2026 · Recall initiated: March 9, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US and Worldwide
- Lot
- ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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