FDA DeviceClass IINotable
FDA Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Mod
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
2026-07-08 · FDA_DEVICE
FDA Recall: ARTIS icono biplane. Model Number: 11327600.
Siemens Medical Solutions USA, Inc
2026-07-08 · FDA_DEVICE
FDA Recall: ARTIS icono ceiling. Model Number: 11328100.
Siemens Medical Solutions USA, Inc
2026-07-08 · FDA_DEVICE
FDA Recall: ARTIS icono ceiling. Model Number: 11328100.
Siemens Medical Solutions USA, Inc
2026-07-08 · FDA_DEVICE
FDA Recall: ARTIS icono floor. Model Number: 11327700.
Siemens Medical Solutions USA, Inc