FDA DeviceClass IINotable
FDA Recall: Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3
Description
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Hazard
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Remedy
51 units
Related Recalls
2026-06-10 · FDA_DEVICE
FDA Recall: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-06-10 · FDA_DEVICE
FDA Recall: Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-06-10 · FDA_DEVICE
FDA Recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-06-10 · FDA_DEVICE
FDA Recall: Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.