MalfunctionLLZ
INTELLISPACE CARDIOVASCULAR
Received Jun 4, 2026 · Event occurred May 7, 2026
Report 3003768277-2026-101173 · MDR key 25391111
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Application Program Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHILIPS IDENTIFIED A SOFTWARE DEFECT INTERNALLY IN THE INTELLISPACE CARDIOVASCULAR (ISCV) THAT A USER CAN AMEND AND FINALIZE A 'FINAL' STUDY THAT HAS NOT BEEN FETCHED FROM THE SERVER OR ARCHIVE, AND IT DOES NOT HAVE ANY IMAGES AVAILABLE. THIS ISSUE IS OBSERVED IN THE ECHO MODULE, AND THE RESULTING BEHAVIOR IS UNDESIRABLE. THE ISSUE WAS IDENTIFIED INTERNALLY AND WAS NOT IN CLINICAL USE AT THE TIME OF EVENT. PHILIPS INVESTIGATION IS ON-GOING.