Dynamic Coronary Roadmap Dynamic Coronary Roadmap - 1Recalls & 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 18, 2026 from official FDA records · Editorial policy

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

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 5

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

5 FDA recall records name this device's identifier, 5 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.

Recalls naming this device

Jan 13, 2025Class IIOpen, 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, 2024Class IIOpen, 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 ↗
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
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
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 ↗

Device details

UDI-DI	`00884838080805`
Brand	Dynamic Coronary Roadmap
Model	Dynamic Coronary Roadmap - 1
Catalog no.	001016
Company	Philips Medical Systems Nederland B.V.
Product code	OWB · Interventional Fluoroscopic X-Ray System
Class	Class 2
FDA submission	K170130
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	Sep 26, 2023

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.

Other Interventional Fluoroscopic X-Ray System devices

Allura Xper FD Allura Xper FD20
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
25 recalls2 deaths3,984 reports
Allura Xper FD Allura Xper FD20
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
23 recalls2 deaths3,614 reports
Azurion Azurion 7 M20
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
32 recalls2 deaths2,308 reports
O-ARM® BI70002000
Medtronic Navigation, Inc. · Interventional fluoroscopic x-ray system
2 recalls1 death3,667 reports
Azurion Azurion 7 M20
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
28 recalls1 death2,176 reports
Allura Xper FD Allura Xper FD10
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
23 recalls2 deaths2,015 reports
Allura Xper FD Allura Xper FD10
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
20 recalls2 deaths1,837 reports
Azurion Azurion 7 M12
Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System
24 recalls2 deaths1,087 reports

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
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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