HeartNavigator HeartNavigator - 2Recalls & reported problems

Philips Medical Systems Nederland B.V. · Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

6 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 6

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838059207), received between Jan 13, 2025 and Jun 6, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

6 FDA recall records name this device's identifier, 6 still open.

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.

Recalls naming this device

Jan 2, 2024Class IIOpen, Classified
Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Z-1156-2024 · Root cause: Process design · Recall details · FDA record ↗
Jan 2, 2024Class IIOpen, Classified
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
Z-1144-2024 · Root cause: Process design · Recall details · FDA record ↗
Jan 2, 2024Class IIOpen, Classified
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Z-1151-2024 · Root cause: Process design · Recall details · FDA record ↗
Jan 2, 2024Class IIOpen, Classified
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Z-1152-2024 · Root cause: Process design · Recall details · FDA record ↗
Jan 2, 2024Class IIOpen, Classified
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
Z-1145-2024 · Root cause: Process design · Recall details · FDA record ↗
Dec 12, 2023Class IIOpen, Classified
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
Z-0835-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Activation Failure1
Positioning Failure1
Radiation Output Failure1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 6, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT POWER ON. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22156336 ↗
MalfunctionFeb 12, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM 3D ROTATIONAL MOVEMENTS. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM WAS REPORTED TO PHILIPS.PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLIANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364535 ↗
MalfunctionJan 13, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE WIRELESS FOOTSWITCH WAS NOT WORKING. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137859 ↗

Device details

UDI-DI	`00884838059207`
Brand	HeartNavigator
Model	HeartNavigator - 2
Catalog no.	001001
Company	Philips Medical Systems Nederland B.V.
Product code	OWB · Interventional Fluoroscopic X-Ray System
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 15, 2025

Device type (GMDN): Angiographic x-ray system application software

An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to an x-ray fluoroscopy based imaging system including x-ray angiography system configurations. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

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All Interventional Fluoroscopic X-Ray System devices →

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 · each recall links to the FDA recall notice
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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