Philips Medical Systems is recalling approximately 51 units of Azurion 3, 5, and 7 medical imaging systems equipped with Certeray generators. The generator can fail due to a short circuit in a specific circuit board assembly known as the Power Inverter. If this short circuit occurs, it causes internal fuses to trip, leading to an immediate loss of power that makes the entire imaging system non-functional during medical procedures. This failure can result in delays or the forced termination of diagnostic and surgical procedures already in progress.
A short circuit in the power inverter's circuit board causes the system to lose power unexpectedly. This poses a significant risk to patients if the equipment fails during a minimally invasive surgery or diagnostic procedure, potentially leading to medical complications due to the interruption of image guidance.
System technical evaluation and repair related to the PCBA in the Power Invertor.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.