Philips North America has recalled several models of its Image Guided Therapy-Systems, including the Integris-Allura, Allura Xper, Azurion, Zenition, Veradius, and BV Endura/Pulsera C-arm systems. These medical imaging devices were delivered to certain regions, specifically Puerto Rico, without required safety warning labels and are missing the Source-to-Skin Distance Spacer (Tube-spacer). These components are critical for ensuring proper distance and safety during radiological procedures.
The absence of the Source-to-Skin Distance Spacer and appropriate warning labels can lead to patients being positioned too close to the radiation source. This increases the risk of accidental overexposure to radiation or skin burns during surgical and diagnostic imaging procedures.
Missing safety components and labeling
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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