MalfunctionPJB
STEREOTAXIS GENESIS RMN WITH NAVIGANT WORKSTATION AND CARDIODRIVE SYSTEM
Received Mar 29, 2023 · Event occurred Feb 14, 2023
Report 16634726 · MDR key 16634726
Device
Generic name
Catheter Remote Control System
Manufacturer
Stereotaxis, Inc.Product problems
- Computer Software Problem
Patient
27740 DA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EQUIPMENT HAD A CPU FAILURE MULTIPLE TIMES. EQUIPMENT HAD TO REBOOT COMPUTER EACH TIME TO RESTORE IMAGING. NO HARM TO PATIENT. VENDOR NOTIFIED.