IntelliSpace Cardiovascular 2.3Recalls & reported problems
Philips Medical Systems Nederland B.V. · Cardiovascular Image and Information Management Solution (CVIS) · Class 2
All models of IntelliSpace Cardiovascular (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838085770), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer System Security Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Computer System Security Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Computer System Security Problem
IT WAS REPORTED TO PHILIPS THAT THE CUSTOMER IS EXPERIENCING PERFORMANCE ISSUES AND A NETWORK THREAT WAS DETECTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT AND NO ADVERSE EVENTS OR HARM WERE REPORTED. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966550 ↗
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, ClassifiedIntelliSpace Cardiovascular, Software 8.0.0.4.
- Z-1740-2025 · Apr 7, 2025 · Open, ClassifiedIntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
- Z-1252-2025 · Apr 4, 2024 · Open, ClassifiedPhilips IntelliSpace Cardiovascular software, Model 830089.
Other System, image processing, radiological devices
- Interventional Workspot Interventional Workspot - 1Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological13 recalls24 reports
- Synapse Radiology PACS Synapse Radiology PACS Software LicenseFujifilm Healthcare Americas Corporation · System, image processing, radiological9 recalls38 reports
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER 7.0Ge Healthcare · System, image processing, radiological6 recalls0 reports
- IntelliSpace Cardiovascular 8Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological2 recalls132 reports
- VMA 2Ortho Kinematics, Inc. · System, Image Processing, Radiological4 recalls0 reports
- CA1000 2.0 SP 14Ge Healthcare · System, image processing, radiological4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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