inforMED
MalfunctionLLZ

INTELLISPACE CARDIOVASCULAR

Received Jun 30, 2026 · Event occurred Jun 1, 2026

Report 3003768277-2026-101205 · MDR key 25663663

Device

Generic name

Cardiovascular Image And Information Management System

Catalog number

830089

Product problems

  • No Display/Image

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE CARDIOVASCULAR (ISCV) INDICATING THAT AN ERROR OCCURRED WHILE REFERENCING IMAGES IN ULTRASOUND (US) VIEWER. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT (B)(4). PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.