IntelliSpace Cardiovascular 8Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 00884838122000), received between Nov 18, 2025 and Sep 30, 2026 — classified as 132 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (34 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 8, 2025Open, Classified

   Software issue that results in the display of outdated information.

   Z-2543-2025 · Root cause: Software design · FDA record ↗

2. 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 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Transmit Record

  Philips received a complaint on the IntelliSearch Cardiovascular (ISCV) indicating that customer reported that study retrieval from the archive was either failing or taking an excessively long time to complete. 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 50944206 ↗
• MalfunctionSep 29, 2026Application Program Problem

  Philips identified an issue internally on the IntelliSpace Cardiovascular (ISCV) indicated that the "Create Order" functionality does not work as expected for the "Reviewer" and "Ordered By" fields. Specifically, users are unable to type a name and select it from the displayed list. The device was not in clinical use at the time of the event, and no adverse event or patient harm was reported (PR 7628767).Philips has started an investigation of this complaint.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930368 ↗
• MalfunctionSep 28, 2026Failure to Transmit Record

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that certain studies can be successfully copied from Enterprise Storage to Local Storage. However, when attempting to copy the study back from Local Storage, the study selection dialog appeared blank. 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 50911664 ↗
• MalfunctionSep 23, 2026Application Program Problem

  Philips received a complaint regarding IntelliSpace Cardiovascular (ISCV), indicating that users experienced error 500 while using the application. 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 50866850 ↗
• MalfunctionSep 23, 2026Application Program Problem

  Philips received a complaint regarding IntelliSpace Cardiovascular (ISCV), indicating that users encountered an application error after new permissions were granted. 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 50866459 ↗
• MalfunctionSep 22, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein archive option fetch time out caused fetch and Digital Imaging and Communications in Medicine (DICOM) Import issues. 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 50858976 ↗
• MalfunctionSep 22, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein data transfer from modalities to ISCV was not working. 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 50857021 ↗
• MalfunctionSep 22, 2026Application Program Problem

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the Digital Imaging and COmmunication in Medicine (DICOM) services were intermittently hanging, requiring the services to be restarted multiple times per week. The device was in clinical use at the time of the event, and 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 50853090 ↗
• MalfunctionSep 21, 2026Application Program Problem

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user experienced slow opening of studies via echo module with lots of priors. 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 50839612 ↗
• MalfunctionSep 21, 2026Failure to Transmit Record

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the user was unable to download either an anonymized or a non-anonymized study. 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 50839161 ↗
• MalfunctionSep 21, 2026Application Program Problem

  Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that user was unable to save the changes or validate the report. The device was in clinical use at the time of the event, and 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 50839158 ↗
• MalfunctionSep 19, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50832491 ↗
• MalfunctionSep 18, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (Intelli Space Cardiovascular) system wherein the Users reporting that they were unable to send or upload 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 50819953 ↗
• MalfunctionSep 18, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein customer that the studies were not coming. 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 50819952 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein thumbnails bar said TTA only allowed one measurement and then "broke" the study. It was no longer possible to open or analyze 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 50818260 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein cleanup 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 50814634 ↗
• MalfunctionSep 17, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein secondary captures could not be sent 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 50800793 ↗
• MalfunctionSep 17, 2026Disconnection

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein error "no connection to backend service" after a timeout when opening semi automated measurement. 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 50800279 ↗
• MalfunctionSep 17, 2026Failure to Transmit Record

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user reported that Q/R (Query/Retrieve) issues from VuePACS (Picture Archiving and Communication System) at the study level. 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 50799349 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that download study was not working. 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 50799229 ↗
• MalfunctionSep 17, 2026Disconnection

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Unable to download 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 50799224 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user reported that image was not in 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 50798176 ↗
• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein Error message when trying to burn a DVD with the cardio PACS. 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 50797547 ↗
• MalfunctionSep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794343 ↗
• MalfunctionSep 16, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788454 ↗

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