IntelliSpace Cardiovascular IntelliSpace Cardiovascular 3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838087460), received between Sep 11, 2026 and Sep 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026No Display/Image

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that some cases could not load all images. 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 50865724 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  22-Sep-2026, (b)(6):The GDTs are reassessed as part of the correction task (b)(4) ¿ Remediation of ISCV complaints (CAPA#6506497). Philips identified a software defect in the ISCV (IntelliSpace Cardiovascular) system wherein user faced conversion error.Although there was no adverse event associated, 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 50853532 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that in ISCV, Ultrasound reporting 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 50813859 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758611 ↗
• MalfunctionSep 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user faced an error stating ¿Saving Digital Image Communication in Medicine (DICOM) Structured Report (SR) data in progress¿ when creating a specific 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 50731916 ↗

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.