IntelliSpace Cardiovascular 4.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00884838095250), received between Mar 4, 2026 and Sep 30, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure to Transmit Record” (5 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 17 most recent of 17 reports, 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 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810311 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein customer was unable to view thumbnails on one 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 50798534 ↗
• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740591 ↗
• MalfunctionSep 11, 2026Failure to Transmit Record

  Philips identified a software defect in IntelliSpace Cardiovascular (ISCV) wherein the user faced an issue with the transfer of an echo 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. 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 50732597 ↗
• MalfunctionSep 11, 2026Application Program Freezes or Fails to Launch

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein system failed to start. 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 50732369 ↗
• MalfunctionSep 10, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717870 ↗
• MalfunctionSep 8, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678315 ↗
• MalfunctionSep 8, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675259 ↗
• MalfunctionSep 7, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658292 ↗
• MalfunctionAug 31, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519908 ↗
• MalfunctionAug 30, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515017 ↗
• MalfunctionAug 25, 2026Application Program Problem

  Philips received a complaint regarding IntelliSpace Cardiovascular (ISCV), indicating that unable to finalize report on Echo Module and encounter an error 500. The device was in clinical use at the time of the event, and no adverse event or patient harm was reported (PR (b)(4)).Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50426773 ↗
• MalfunctionMay 7, 2026Communication or Transmission Problem

  IT WAS REPORTED TO PHILIPS THAT TEST DATA CANNOT BE WRITTEN TO CD/DVD ON ALL WORKSTATIONS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115793 ↗
• MalfunctionApr 6, 2026Failure to Transmit Record

  PHILIPS IDENTIFIED A DEFECT IN INTELLISPACE CARDIOVASCULAR (ISCV) IN WHICH A SYNCHRONIZATION ISSUE BETWEEN THE FETCH AND IMPORT PROCESSES (RACE CONDITION) MAY OCCUR WHEN THE STUDY IS OFFLINE, POTENTIALLY LEADING TO DELETION OF NEWLY IMPORTED DATA FOLLOWING A FETCH FAILURE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. 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, PHILIPS HAS DETERMINED THAT THIS CONSTITUTES A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794206 ↗
• MalfunctionMar 30, 2026Application Program Problem

  IT WAS REPORTED TO PHILIPS THAT DURING ONE OF THE STUDIES, THE PHYSIOLOGIST GOT AN ERROR IN THE ISCV SYSTEM AND WAS NOT ABLE TO RETRIEVE THE MEASUREMENTS MADE ON THE STUDY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720892 ↗
• MalfunctionMar 4, 2026No Display/Image

  PHILIPS IDENTIFIED A SOFTWARE DEFECT IN ISCV (INTELLISPACE CARDIOVASCULAR) WHEREIN DURING ISCV (INTELLISPACE CARDIOVASCULAR) INSTALLATION, THE DATA (SONOGRAPHY IMAGES, ETC.) WERE DELETED AFTER JUST THREE DAYS; STUDIES WERE BEING STORED IN THE REPOSITORY ONLY FOR 3 DAYS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO ADVERSE EVENTS OR HARM WERE REPORTED IN THE COMPLAINT. ALTHOUGH NO ADVERSE EVENTS OR PATIENT HARM WERE REPORTED IN THE ASSOCIATED COMPLAINT (B)(4). 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 24506065 ↗

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.