VesselNavigator VesselNavigator - 1Recalls & reported problems
Philips Medical Systems Nederland B.V. · Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838064775), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Radiation Output Failure” (1 report).
3 FDA recall records name this device's identifier, 3 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
Recalls naming this device
- 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 ↗
- 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 ↗
- 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
- Radiation Output Failure1
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.
MalfunctionDec 4, 2024Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S WIRED FOOTSWITCH STOPPED RESPONDING, WHICH CAN IMPACT IMAGING. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF 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 20842722 ↗
Other System, Image Processing, Radiological devices
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- CENTRICITY UNIVERSAL VIEWER ZFP CLIENT 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
- CENTRICITY UNIVERSAL VIEWER 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
- CA1000 2.0 SP 14Ge Healthcare · System, image processing, radiological4 recalls0 reports
- VMA 2Ortho Kinematics, Inc. · 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 · 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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