InjuryOWB
ARTIS ICONO BIPLANE
Received Jun 26, 2026 · Event occurred Jun 17, 2026
Report 3004977335-2026-00116 · MDR key 25634821
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Siemens Healthineers AgModel number
11327600Product problems
- Poor Quality Image
- Poor Visibility
Patient
Not reported
- Visual Impairment
Narrative
Description of Event or Problem
SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING ARTIS ICONO BIPLANE SYSTEM. DURING AN EMBOLIZATION PROCEDURE, THE USER REPORTED BAD GLUE VISIBILITY. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT DEVELOPED A VISUAL DISABILITY AS A RESULT OF THE PROCEDURE.
Additional Manufacturer Narrative
SIEMENS IS CONDUCTING A DETAILED INVESTIGATION OF THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.