IntelliSpace Portal IntelliSpace Portal - 12Recalls & reported problems

Philips Medical Systems Nederland B.V. · IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications. · Class 2

Data updated Oct 18, 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 00884838093621), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Readings” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

High Readings1

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.

MalfunctionAug 28, 2024High Readings; High Readings
IT HAS BEEN REPORTED TO PHILIPS BY THE FINNISH MEDICINES AGENCY (REFERENCE (B)(4)), THAT ONE OF PHILIPS APPLICATIONS, USED IN TAYS SYDÄNSAIRAALA HOSPITAL, WHICH MEASURES LEFT VENTRICULAR VOLUME, GIVES DIFFERENT RESULTS THAN OTHER VENDORS GIVE FOR THE SAME DATA. AS DESCRIBED, IF THE RESULTS WE GIVE ARE SIGNIFICANTLY WRONG, IT MAY RESULT IN UNNECESSARY INTERVENTIONAL TREATMENT. THERE IS NO ALLEGATION OF PATIENT OR USER HARM. DURING ROUTINE ACTIVITIES, THE CUSTOMER IDENTIFIED AN UNUSUALLY HIGH VOLUME FOR THE LEFT VENTRICLE OF A PATIENT WHILE USING THE PHILIPS INTELLISPACE SOFTWARE FOR MEASURING CARDIAC MRI VOLUMES AND FLOWS. ON 02-AUG-2024 AN ESCALATION FROM THE COMPETENT AUTHORITIES WAS RECEIVED BY PHILIPS (FIMEA-V163069). THERE WAS NO HARM REPORTED TO THE PATIENT. THE RECORD (B)(4) FINLAND USER REPORT - (B)(4) WAS REVIEWED, AND IT WAS CONFIRMED THAT THE SOFTWARE CURRENTLY BEING INVESTIGATED IS THE MR CARDIAC ANALYSIS WITHIN INTELLISPACE PORTAL (SOFTWARE VERSION 12.1.8) AT TAYS HEART HOSPITAL (TAYS SYDANKESKUS OY). SUMMARIZED SEQUENCE OF EVENTS AS CONFIRMED IN A MEETING WITH THE CUSTOMER ON 16-OCT-2024: CARDIAC CINE MR DATA IS LOADED IN CMR APPLICATION FOR FUNCTION ANALYSIS. FOR SEGM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20084468 ↗

Device details

UDI-DI	`00884838093621`
Brand	IntelliSpace Portal
Model	IntelliSpace Portal - 12
Catalog no.	30001351160X
Company	Philips Medical Systems Nederland B.V.
Product code	LLZ · System, image processing, radiological
Class	Class 2
FDA submission	K162025
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Apr 30, 2025

Device type (GMDN): Radiology DICOM image processing application software

A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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