IntelliSpace Cardiovascular 5Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00884838100107), received between Mar 3, 2026 and Sep 30, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• 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 22, 2026No Display/Image

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the study was successfully transferred; however, several images were missing from the transferred study. 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 50851253 ↗
• MalfunctionSep 22, 2026Failure to Transmit Record

  Philips received a complaint regarding IntelliSpace Cardiovascular (ISCV) indicating an issue with the transfer of patient images, where studies were not transferred completely. 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 50851178 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Recurring error preventing the finalization of 3 examinations. 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 50802660 ↗
• MalfunctionSep 17, 2026Computer Software Problem

  Philips identified a software defect internally in ISCV (IntelliSpace Cardiovascular) wherein with each version, there were bugs that impacted users, and no satisfactory workaround was available. The issue was identified internally and was not 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 50802650 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that Reporting in thick client causing issue with further reporting in thin client. 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 50801266 ↗
• MalfunctionSep 17, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein an examination in particular was impossible to transfer. 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 50798645 ↗
• MalfunctionSep 17, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user reported that some studies could not be uploaded. 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 50798415 ↗
• MalfunctionSep 17, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system where images were in Picture Archiving and Communication System (PACS), but PACS was unable to send them to ISCV. 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 50798177 ↗
• MalfunctionSep 16, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796508 ↗
• MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794891 ↗
• MalfunctionSep 16, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794722 ↗
• MalfunctionSep 16, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785190 ↗
• MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784866 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780030 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that Error when saving the study. 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 50776085 ↗
• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user encountered error 500 when opening studies.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 50770476 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763013 ↗
• MalfunctionSep 14, 2026No Device Output

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was unable to finalize the report. 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 or misdiagnosis. 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 50749510 ↗
• MalfunctionSep 11, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that Digital Imaging Communication in Medicine (DICOM) import was crashing often. 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 50729763 ↗
• MalfunctionSep 11, 2026Application Program Freezes or Fails to Launch

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that ISCV was not Working- Frequent system failures. 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 50728783 ↗
• MalfunctionSep 11, 2026Intermittent Communication Failure

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein a problem accessing the server for the synchronization of the accounts, in fact a doctor cannot use his ISCV account. 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 50728554 ↗
• MalfunctionSep 11, 2026No Device Output

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein thumbnails images were missing in study view screen but in Cath Viewer all images exist and viewable. 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 50725900 ↗
• MalfunctionSep 11, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the data transfers between the scanner and PACS have stopped since this morning. 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 50725674 ↗
• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the reports manager was in problem. 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 50717419 ↗

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.