FDAFDA · Food and drugs·Recall number Z-2205-2026
ARTIS pheno, Model 10849000. 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
- UDI: 4056869046877
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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