INTELLISPACE CARDIOVASCULAR
Received Apr 17, 2026 · Event occurred Mar 18, 2026
Report 3003768277-2026-101063 · MDR key 24907626
Device
Generic name
Cardiovascular Image And Information Management System
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INTELLISPACE CARDIOVASCULARCatalog number
830089
Product problems
- Computer System Security Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT HAS BEEN REPORTED TO PHILIPS THAT THE CUSTOMER HAS RECEIVED SUSPICIOUS COMMANDS EXECUTED BY A "PHILIPS" SERVICE ACCOUNT. CUSTOMER WOULD LIKE TO CONFIRM WHETHER THIS WAS LEGITIMATE. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Additional Manufacturer Narrative
IT HAS BEEN REPORTED TO PHILIPS THAT THE CUSTOMER HAS RECEIVED SUSPICIOUS COMMANDS EXECUTED BY A "PHILIPS" SERVICE ACCOUNT. CUSTOMER WOULD LIKE TO CONFIRM WHETHER THIS WAS LEGITIMATE. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. THE COMPLAINT CONTAINED NO ALLEGATION OF SERIOUS INJURY OR DEATH. BASED ON THE RESULTS OF THE ANALYSIS, INTELLISPACE CARDIOVASCULAR (ISCV) L2 SERVICE ENGINEER WORKED ON THIS SERVER THE NIGHT BEFORE FOR THIS CASE WAS RAISED. THIS WAS LEGITIMATE WORK. ISCV WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THIS RECORD IS CONSIDERED TO BE NON-REPORTABLE. NOTES: THE INITIAL EMDR WAS SUBMITTED WITH INCORRECT CATALOG ITEM IDENTIFIER AND PRODUCT UDI. THEY WERE CORRECTED. EVALUATION RESULTS FDA C-CODE AND CONCLUSION FDA C-CODE WERE UPDATED.