ARTIS ICONO BIPLANE
Received Jun 16, 2026 · Event occurred May 17, 2026
Report 3004977335-2026-00104 · MDR key 25519235
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Siemens Healthineers AgModel number
11327600Product problems
- Radiation Output Problem
- Radiation Output Failure
Patient
Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
SIEMENS BECAME AWARE OF AN EVENT THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING A PATIENT PROCEDURE, NO X-RAY IMAGING ON EITHER PLANE WAS POSSIBLE. IT WAS REPORTED THAT THE PATIENT HAD A BRAIN RUPTURE, HOWEVER, THE CIRCUMSTANCES REMAIN UNCLEAR AND NO FURTHER INFORMATION WAS RECEIVED IN REGARDS TO THE HEALTH OF THE PATIENT. SIEMENS REQUESTED ADDITIONAL INFORMATION REGARDING THIS EVENT.