Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 3Recalls & reported problems
Philips Medical Systems Nederland B.V. · Software medical device, used with a Philips Interventional X-Ray System. Intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. · Class 2
All models of Dynamic Coronary Roadmap (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884838101883), received between Nov 18, 2024 and Sep 12, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Radiation Output Failure” (4 reports).
2 FDA recall records name this device's identifier, 2 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 16, 2026.
Reports received per month
Recalls naming this device
- Jan 2, 2024Open, 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, 2023Open, 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 Failure4
- Activation Failure3
- No Display/Image3
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GENERATED A REMOTE ALERT INDICATING "RMT - XGC: TUBE CURRENT OUT OF RANGE. ERROR AZURION - FRONTAL", WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038454 ↗MalfunctionSep 9, 2025Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S X-RAY TUBE FAILED, WHICH CAN IMPACT IMAGING. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003148 ↗MalfunctionSep 3, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S FLEXVISION MONITOR WAS UNABLE TO DISPLAY LIVE IMAGES. 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 22951491 ↗MalfunctionSep 2, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION COMPUTER WAS UNABLE TO BOOT UP. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22948854 ↗MalfunctionJun 5, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM TURNED BLACK DURING USE, WHICH COULD IMPACT IMAGING. 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 22147578 ↗MalfunctionMay 30, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS NOT BOOTING UP. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22112474 ↗MalfunctionMay 22, 2025No Display/Image; No Display/Image
IT WAS REPORTED TO PHILIPS THAT THE FLEXVISION MONITOR WAS UNABLE TO DISPLAY LIVE AND REFERENCE IMAGES. THE DEVICE WAS IN 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 22072471 ↗MalfunctionJan 27, 2025Activation Failure; Activation Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOT BACK UP. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21239235 ↗MalfunctionNov 26, 2024Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THERE WAS A CONNECTION ISSUE WITH THE WIRELESS FOOTSWITCH. 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 20781529 ↗MalfunctionNov 18, 2024Radiation Output Failure; Radiation Output Failure
IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO PERFORM X-RAYS. 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 20713386 ↗
Other Interventional Fluoroscopic X-Ray System devices
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- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths3,614 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System32 recalls2 deaths2,308 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system2 recalls1 death3,667 reports
- Azurion Azurion 7 M20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System28 recalls1 death2,176 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths2,015 reports
- Allura Xper FD Allura Xper FD10Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System20 recalls2 deaths1,837 reports
- Azurion Azurion 7 M12Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System24 recalls2 deaths1,087 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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