Philips Medical Systems Nederland B.V. is recalling 9,707 units (2,300 in the US and 7,407 internationally) of the Azurion R1.x and R2.x imaging systems across all software versions. A software communication error was identified that can lead to a sudden and total loss of X-ray imaging functionality during medical procedures. These systems were sold directly to medical facilities and through hospital equipment suppliers.
The loss of imaging functionality can cause critical delays during urgent medical interventions for life-threatening conditions, such as strokes, heart attacks, or severe bleeding. Such delays can result in serious health complications, permanent injury, or death.
Affected software version: All software versions. Some model numbers (15, 16, 17) were not commercialized in the US.
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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