Philips North America is recalling 56 units of the Ingenia Ambition X and Ingenia Ambition S MRI systems in the United States and 169 units worldwide. These medical imaging devices contain a sealed magnet that can undergo an uncontrolled shutdown, known as a Loss-of-Field (LoF), if the system loses its cryo-cooling capability, such as during a building power outage. This sudden loss of the magnetic field can disrupt clinical operations and may lead to diagnostic delays or safety concerns during the shutdown process.
If the MRI magnet loses cooling, it may shut down unexpectedly and uncontrollably, potentially damaging the equipment or creating a safety hazard in the scanning room during the rapid loss of the magnetic field. This issue is specifically triggered by external factors like on-site power outages that interrupt the system's cooling mechanism.
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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.
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Sources: FDA iRES · Raw API Response
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