Dynamic Coronary RoadmapRecalls & reported problems across all models
Philips Medical Systems Nederland B.V. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
9 open recalls name at least one Dynamic Coronary Roadmap model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 9
We found 3 models of Dynamic Coronary Roadmap by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, 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).
9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Dynamic Coronary Roadmap recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 13, 2025Open, Classified
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Z-1078-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Aug 22, 2024Open, Classified
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Z-3166-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Z-1177-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jan 2, 2024Open, 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, 2024Open, 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, 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 · names 2 of these models · Recall details · FDA record ↗
- 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-1151-2024 · Root cause: Process design · Recall details · FDA record ↗
- Jan 2, 2024Open, 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 ↗
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Dynamic Coronary Roadmap problems
Device problems
- Radiation Output Failure4
- Activation Failure3
- No Display/Image3
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Dynamic Coronary Roadmap models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 1Interventional Fluoroscopic X-Ray System5 recalls0 reports
- Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 2Interventional Fluoroscopic X-Ray System4 recalls0 reports
- Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 3Interventional Fluoroscopic X-Ray System2 recalls10 reports
Recent Dynamic Coronary Roadmap adverse event reports
The 10 most recent reports across all models, 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 Philips Medical Systems Nederland B.V. products
- Allura Xper FD19 models · 15,187 reports · 84 recalls
- Azurion22 models · 9,199 reports · 71 recalls
- Ingenia54 models · 479 reports · 138 recalls
- IntelliSpace Cardiovascular11 models · 439 reports · 3 recalls
- MR 7000 Series2 models · 4 reports · 11 recalls
- MR 5000 Series3 models · 11 reports · 8 recalls
- Brilliance iCT2 models · 9 reports · 8 recalls
- Zenition2 models · 101 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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