IntelliSpace Cardiovascular IntelliSpace Cardiovascular 4.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00884838093072), received between Dec 11, 2025 and Sep 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K153022); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796754 ↗
• MalfunctionSep 9, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692191 ↗
• MalfunctionSep 8, 2026Data Back-Up Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674977 ↗
• MalfunctionAug 31, 2026Application Program Freezes or Fails to Launch

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the user could not log into system. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, it is determined that this constitutes a reportable malfunction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516576 ↗
• MalfunctionJul 30, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50083723 ↗
• MalfunctionApr 24, 2026Application Program Problem

  PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV (INTELLISPACE CARDIOVASCULAR) WHEREIN THE USER WAS HAVING ISSUES WITH DIGITAL IMAGING AND COMMUNICATION IN MEDICINE (DICOM) STRUCTURED REPORT (SR). THE USER WAS UNABLE TO COMPLETE THE REPORT AS AN ERROR MESSAGE APPEARED IN THE ¿LOAD NEW IMAGES AND/OR DATA¿ TAB. NO ADVERSE EVENTS OR PATIENT HARM WAS REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. ALTHOUGH NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT, THIS MALFUNCTION HAS BEEN DETERMINED TO BE REPORTABLE. UNDER SPECIFIC CIRCUMSTANCES, IT COULD POTENTIALLY LEAD TO DELAYED DIAGNOSIS OR MISDIAGNOSIS. GIVEN THE DEFECT¿S NATURE AND ITS POTENTIAL IMPACT ON CLINICAL DECISION-MAKING IF IT WERE TO RECUR, PHILIPS HAS DETERMINED THAT THIS CONSTITUTES A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980919 ↗
• MalfunctionMar 31, 2026Application Program Problem

  PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV (INTELLISPACE CARDIOVASCULAR) SYSTEM WHEREIN THE POWERSHELL SCRIPT EXECUTION RIGHTS ADJUSTED FROM "UNRESTRICTED" TO "ALL SIGNED". THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. BASED ON THE NEW INFORMATION THAT PHILIPS BECAME AWARE, THIS HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION. UNDER SPECIFIC CIRCUMSTANCES, IT COULD POTENTIALLY LEAD TO DELAYED DIAGNOSIS. GIVEN THE DEFECT¿S NATURE AND ITS POTENTIAL IMPACT ON CLINICAL DECISION-MAKING IF IT WERE TO RECUR, IT IS DETERMINED THAT THIS CONSTITUTES A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740108 ↗
• MalfunctionDec 11, 2025Installation-Related Problem; Installation-Related Problem

  PHILIPS IDENTIFIED A SOFTWARE DEFECT IN INTELLISPACE CARDIOVASCULAR (ISCV) WHEREIN THE UPGRADE OF INTELLISPACE CARDIOVASCULAR (ISCV) 4.1 TO INTELLISPACE CARDIOVASCULAR (ISCV) 8.1 FAILED. THE ISSUE WAS IDENTIFIED OUTSIDE OF CLINICAL USE AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT ((B)(4)). PHILIPS IS CURRENTLY UPDATING THE RISK MANAGEMENT MATRIX FOR THE ISCV PRODUCT. UNTIL THIS UPDATE IS COMPLETE, AND IN AN ABUNDANCE OF CAUTION, PHILIPS IS SUBMITTING A REGULATORY REPORT FOR ALL ISCV (INTELLISPACE CARDIOVASCULAR) PRODUCT MALFUNCTIONS ALLEGED IN COMPLAINT INVESTIGATIONS RELATING TO DATA AVAILABILITY UNTIL THE UPDATE OF THE RISK MANAGEMENT MATRIX IS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777105 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153022. One submission often covers many models, so check the product and lot details in each record.

• Z-2543-2025 · Aug 8, 2025 · Open, Classified
  IntelliSpace Cardiovascular, Software 8.0.0.4.
• Z-1740-2025 · Apr 7, 2025 · Open, Classified
  IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
• Z-1252-2025 · Apr 4, 2024 · Open, Classified
  Philips IntelliSpace Cardiovascular software, Model 830089.