inforMED
MalfunctionPJB

STEREOTAXIS GENESIS RMN WITH NAVIGANT WORKSTATION AND CARDIODRIVE SYSTEM

Received Mar 29, 2023 · Event occurred Feb 15, 2023

Report 16634745 · MDR key 16634745

Device

Generic name

Catheter Remote Control System

Manufacturer

Stereotaxis, Inc.

Product problems

  • Computer Software Problem

Patient

25550 DA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

X-RAY EQUIPMENT FOR CPU FAILURE AGAIN. EQUIPMENT REBOOTED TO RESTORE IMAGING. NO HARM TO THE PATIENT. VENDOR NOTIFIED.