MalfunctionPJB
STEREOTAXIS SYSTEM
Received Nov 7, 2025 · Event occurred Oct 29, 2025
Report MW5178641 · MDR key 23498049
Device
Generic name
Catheter Remote Control System
Manufacturer
Omega Medical Imaging Inc. / Stereotaxis, Inc.Model number
CS20Product problems
- Defective Device
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PVC ABLATION WHEN BOTH THE STEREOTAXIS SYSTEM AND FLUOROSCOPY FAILED, RESULTING IN THE PROCEDURE BEING ABORTED.