IntelliSpace CardiovascularRecalls & reported problems across all models

We found 11 models of IntelliSpace Cardiovascular by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 439 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2023 and Sep 30, 2026 — classified as 439 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (131 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

IntelliSpace Cardiovascular recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 8, 2025Open, Classified

   Software issue that results in the display of outdated information.

   Z-2543-2025 · Root cause: Software design · Recall details · FDA record ↗

2. Apr 7, 2025Open, Classified

   An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.

   Z-1740-2025 · Root cause: Software in the Use Environment · names 3 of these models · Recall details · FDA record ↗

3. Apr 4, 2024Open, Classified

   Study data is not able to be archived, copied, or exported with the cardiovascular software version.

   Z-1252-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported IntelliSpace Cardiovascular problems

IntelliSpace Cardiovascular models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IntelliSpace Cardiovascular 8

  System, Image Processing, Radiological
  2 recalls132 reports
• IntelliSpace Cardiovascular 7

  System, Image Processing, Radiological
  2 recalls99 reports
• IntelliSpace Cardiovascular 6

  System, image processing, radiological
  1 recall118 reports
• IntelliSpace Cardiovascular 5

  System, image processing, radiological
  52 reports
• IntelliSpace Cardiovascular 4.2

  System, image processing, radiological
  17 reports
• IntelliSpace Cardiovascular IntelliSpace Cardiovascular 4.1

  System, image processing, radiological
  8 reports
• IntelliSpace Cardiovascular IntelliSpace Cardiovascular 3.1

  System, image processing, radiological
  5 reports
• IntelliSpace Cardiovascular 3.2

  System, image processing, radiological
  5 reports
• IntelliSpace Cardiovascular IntelliSpace Cardiovascular 1.2

  System, image processing, radiological
  1 report
• IntelliSpace Cardiovascular 2.3

  System, image processing, radiological
  1 report
• IntelliSpace Cardiovascular 9

  System, Image Processing, Radiological
  1 report

Recent IntelliSpace Cardiovascular adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950959 ↗
• MalfunctionSep 30, 2026Computer System Security Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946545 ↗
• MalfunctionSep 30, 2026No Display/Image

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that it was not possible to view previous studies in Echo Module. 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 50944662 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user could not save the findings. 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 50944517 ↗
• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that DICOM import crashed occasionally as there was a PDFClinicalContentExecuter error.. 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 50944390 ↗
• MalfunctionSep 30, 2026Failure to Transmit Record

  Philips received a complaint on the IntelliSearch Cardiovascular (ISCV) indicating that customer reported that study retrieval from the archive was either failing or taking an excessively long time to complete. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944206 ↗
• MalfunctionSep 30, 2026Application Program Problem

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the ISCV could only be accessed in Web-Only mode on the workstation. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942870 ↗
• MalfunctionSep 29, 2026Application Program Problem

  Philips identified an issue internally on the IntelliSpace Cardiovascular (ISCV) indicated that the "Create Order" functionality does not work as expected for the "Reviewer" and "Ordered By" fields. Specifically, users are unable to type a name and select it from the displayed list. The device was not in clinical use at the time of the event, and no adverse event or patient harm was reported (PR 7628767).Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930368 ↗
• MalfunctionSep 29, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928550 ↗
• MalfunctionSep 28, 2026Failure to Transmit Record

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that certain studies can be successfully copied from Enterprise Storage to Local Storage. However, when attempting to copy the study back from Local Storage, the study selection dialog appeared blank. The device was not 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911664 ↗
• MalfunctionSep 25, 2026Computer System Security Problem

  Philips identified an internal software defect in the IntelliSpace Cardiovascular (ISCV) system whereby Server Message Block (SMB) signing is not mandatorily enforced on remote hosts. There is no allegation of death, serious injury, or adverse event associated with this issue.This security weakness could allow an attacker with prior access to the ISCV network to intercept or manipulate communications between systems, potentially leading to unauthorized access to sensitive patient information (PHI/PII), modification of image repository files, or other unauthorized file operations. Under certain circumstances, compromised medical images or patient data could be relied upon for clinical decision-making, potentially resulting in misdiagnosis, delayed or missed critical findings.Therefore, although the issue was identified internally and exploitation requires prior network access, the potential impact on the integrity of diagnostic information and subsequent clinical decision-making supports classification of this issue as a reportable malfunction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897781 ↗
• MalfunctionSep 24, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884307 ↗
• MalfunctionSep 23, 2026Application Program Problem

  Philips received a complaint regarding IntelliSpace Cardiovascular (ISCV), indicating that users experienced error 500 while using the application. The device was in clinical use at the time of the event. No adverse events or harm were reported in the complaint (PR#(b)(4)).Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866850 ↗
• MalfunctionSep 23, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that the retrieve as Secure copy protocol (SCP) Issue. 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 50866579 ↗
• MalfunctionSep 23, 2026Application Program Problem

  Philips received a complaint regarding IntelliSpace Cardiovascular (ISCV), indicating that customer was experiencing a problem where the application started in web-only mode. The device was in clinical use at the time of the event. No adverse events or harm were reported in the complaint (PR# (b)(4).Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866463 ↗

Other Philips Medical Systems Nederland B.V. products

• Allura Xper FD19 models · 15,187 reports · 84 recalls
• Azurion22 models · 9,199 reports · 71 recalls
• Ingenia54 models · 479 reports · 138 recalls
• MR 7000 Series2 models · 4 reports · 11 recalls
• Dynamic Coronary Roadmap3 models · 10 reports · 9 recalls
• MR 5000 Series3 models · 11 reports · 8 recalls
• Brilliance iCT2 models · 9 reports · 8 recalls
• Zenition2 models · 101 reports · 5 recalls