Class II
Medical Device Recall: ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc · March 9, 2026
Reason for Recall
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.
Distribution
US and Worldwide
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2205-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.