MalfunctionOWB
ARTIS ICONO CEILING
Received Jun 12, 2026 · Event occurred Jun 2, 2026
Report 3004977335-2026-00101 · MDR key 25485379
Device
Generic name
Interventional Fluoroscopic X-ray System
Manufacturer
Siemens Healthineers AgModel number
11328100Product problems
- Activation Failure
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 CEILING SYSTEM. DURING THE PATIENT PROCEDURE, THE FLAT DETECTOR LIFT MOVEMENT LOCKED AFTER BOOT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.