IntelliSpace Cardiovascular 7Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00884838115378), received between Nov 6, 2025 and Sep 30, 2026 — classified as 99 malfunctions.

The most frequently reported specific device problem is “Failure to Transmit Record” (27 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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.

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 · Recall details · FDA record ↗

2. 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 problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Computer System Security Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946545 ↗
• 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, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928550 ↗
• MalfunctionSep 24, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884307 ↗
• 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 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that the Query as fails with A900 error after upgrading from 4.2.1.0 to 7.1.0.0. 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 50866352 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that images not displayed with an error message stating "Image data not ready 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 50855949 ↗
• MalfunctionSep 22, 2026No Device Output

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that new failing study where two folders registered in the repository for the same 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 50853536 ↗
• MalfunctionSep 22, 2026No Display/Image

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein some images could not be displayed. 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 50853517 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that the studies could not be re-analyzed with repo-only configuration. 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 50851581 ↗
• MalfunctionSep 21, 2026Failure to Transmit Record

  Philips received a complaint on the Intelli Space Cardiovascular (ISCV) indicating that the images of a catheterization patient could not be retrieved. 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 50838147 ↗
• MalfunctionSep 19, 2026Failure to Transmit Record

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50832497 ↗
• 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 Previous reports can not be seen. 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 50816256 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein thumbnails bar said when they tried to open any study, a syntax error appeared. 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 50816255 ↗
• MalfunctionSep 17, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Fetching problems ISCV gets stuck (some study is blocking it). 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 50805666 ↗
• MalfunctionSep 17, 2026Application Program Freezes or Fails to Launch

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system where Users Get HTTP 503 Error when logging in. 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 50805659 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Customer reported Issue in the SAM (Software Asset Management) tool in the server wherein it crashes when going to the user list. 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 50800657 ↗
• MalfunctionSep 17, 2026Application Program Problem

  Philips identified a software defect in the ISCV (IntelliSpace Cardiovascular) system wherein application pool was disabled due to a worker process failure. 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 50799343 ↗
• MalfunctionSep 17, 2026Unintended Application Program Shut Down

  Philips identified a software defect internally in ISCV (IntelliSpace Cardiovascular) wherein SAM Tool crashed when the User Info tab was clicked. 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 50799107 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported an intermittent internal server error 500 when saving work. 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 50798538 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein user couldn't access 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 50798305 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user reported that the study images are not transferred to ISCV, it happens in several equipment's . 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 50797802 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein all ISCV users could not access the application with an error message "HTTP Error 503. The service is unavailable.". 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 50797801 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that there was no connection with server and therefore, the user could not send the reports. 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 50797521 ↗

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.