FDA DeviceClass IINotable
FDA Recall: ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Description
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.
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.
Related Recalls
2026-06-10 · FDA_DEVICE
FDA Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Mod
Siemens Medical Solutions USA, Inc
2026-04-22 · FDA_DEVICE
FDA Recall: ARTIS Pheno VE30A and VE40A, Model 10849000
Siemens Medical Solutions USA, Inc
2026-04-15 · FDA_DEVICE
FDA Recall: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100,
Siemens Medical Solutions USA, Inc