This recall affects 56 Canon Medical Vantage Galan 3T and Vantage Titan 3T MRI systems due to a defect in the superconducting magnet's venting system. Ice can form inside the vent path, which may prevent helium gas from escaping if the magnet loses its cooling properties (a process known as a 'quench'). If the gas cannot escape through the intended path, pressure can build up inside the cooling tank, potentially causing it to rupture and release helium gas into the patient scanning room.
A rupture of the helium vessel could release high volumes of helium gas into the MRI scanning room. This poses a serious risk of suffocation by displacing oxygen or physical injury from the structural failure of the pressurized tank.
Quantity: 34 systems
Quantity: 22 systems
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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