MalfunctionOWB
ARTIS ICONO BIPLANE
Received Jun 12, 2026 · Event occurred Jun 1, 2026
Report 3004977335-2026-00100 · MDR key 25485037
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Siemens Healthineers AgModel number
11327600Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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 WAS INFORMED ABOUT A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE. DURING THE PATIENT PROCEDURE, ALL SYSTEM MOVEMENTS WERE BLOCKED. THE PROCEDURE WAS COMPLETED ON THE SAME SYSTEM. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.