inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received May 12, 2026 · Event occurred Apr 28, 2026

Report 3003768277-2026-101126 · MDR key 25147382

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • Application Program Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT HAS BEEN REPORTED TO PHILIPS THAT THERE WAS RE-ARCHIVING OF ALL EXAMS DUE TO NEW REPORT IN ISCV (INTELLISPACE CARDIOVASCULAR). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.