inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jul 11, 2026 · Event occurred Oct 29, 2025

Report 3003768277-2026-101246 · MDR key 25790005

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Computer System Security Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER PERFORMED PENETRATION TESTING ON THE ISCV TEST SERVER OUTSIDE OF CLINICAL USE AND HAS QUESTIONS ABOUT UNUSED SECURITY HEADER. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS INVESTIGATION IS ONGOING.