IntelliSpace Cardiovascular 6Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00884838106970), received between Sep 28, 2023 and Sep 30, 2026 — classified as 118 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (61 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• 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 23, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that the query retrieves as failed from UWS 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 50866351 ↗
• MalfunctionSep 22, 2026Loss of Data

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein images were missing in a 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 50854162 ↗
• MalfunctionSep 21, 2026Image Display Error/Artifact

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that the thumbnail views of the new CT (Computed Tomography) were displayed inverted. 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 50840632 ↗
• MalfunctionSep 21, 2026No Display/Image

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user faced an issue where image data was not ready. 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 50839621 ↗
• MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein users were unable to load archived cases with images more than 2GB which affecting clinical workflow. 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 50839615 ↗
• MalfunctionSep 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported an error when trying to save 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. 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 50838327 ↗
• MalfunctionSep 21, 2026Communication or Transmission Problem

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that the archiving errors noticed in log files. 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 50838148 ↗
• MalfunctionSep 19, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50832609 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein customer reported that study showed an error while processing SR data. 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 50818257 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reported that Unable to save 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 50816128 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in the ISCV (IntelliSpace Cardiovascular) system user reported about data loss for patient. 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 50815628 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Performance issues on ISCV Application server. 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 50815483 ↗
• MalfunctionSep 18, 2026No Device Output

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that the PasoPI services were unable to startup after installation. 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 50815346 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user encountered 'Image Data not ready' error message. 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 50815341 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the customer facing Error while processing DICOM SR data. 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 50814743 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported about report present under wrong patient. 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 50802442 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in the ISCV (IntelliSpace Cardiovascular) system wherein image data was not ready for stress studies.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 50802441 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein existing bug 1555569 was identified in the case by the customer service team during the troubleshooting of performance issue reported by the customer. 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 50801006 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein no images or loops were displayed in the echo module for a 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 50800791 ↗
• MalfunctionSep 17, 2026Computer Operating System Problem

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Error messaging when logging on to ISCV issues today/yesterday. 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 50800083 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user reported the problems with HTTP (HyperText Transfer Protocol) error 503 in 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 50799344 ↗
• MalfunctionSep 17, 2026Display or Visual Feedback Problem

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein image data not ready as the converter was not working properly. 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 50799111 ↗
• 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 the data loss for the patient. 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 50798986 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein thumbnails bar said application error appeared while opening study in Echo Module Web. 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 50798306 ↗

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-1252-2025 · Apr 4, 2024 · Open, Classified
  Philips IntelliSpace Cardiovascular software, Model 830089.