PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1,
Philips Medical Systems Nederland B.V. initiated a Class II recall for the Azurion 3M15 system due to a software defect in the Roadmap Pro feature. A 'pedal tap'—a brief footswitch activation without X-ray generation—can cause the subsequent fluoroscopy run to produce a dark image that is not clinically usable.
Manufacturers and operators of interventional X-ray systems, specifically clinical staff in radiology or surgical suites using Philips Azurion 3M15 models 722064 and 722222 with software releases R2.2.0 through R2.2.6.
This recall highlights a specific software logic error where a minor user interaction (pedal tap) triggers a failure in the image processing sequence. For regulatory teams, it underscores the importance of validating software state-machine transitions and user interface interactions that might inadvertently impact diagnostic image quality during active procedures.
QA and Clinical teams should identify if the specific software releases (R2.2.0 through R2.2.6) and Roadmap Pro software keys are in use. Users should be briefed on the technical risk of 'pedal tapping' and the resulting potential for image degradation until a software patch is implemented.
Class II. Reason: 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.. Product: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key. Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (Best Netherlands). Status: Ongoing.
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