Canon Medical System, USA, INC. has recalled two VANTAGE GALAN 3T MRI systems (Model MEXL-3020/B7). The affected systems contain components that do not meet the required safety distance between electrodes as defined by international standards for medical electrical equipment. Facility managers or clinical staff should contact Canon Medical Systems to arrange for a correction of the affected equipment.
The distance between internal electrodes does not meet compliance standards, which could potentially compromise the electrical safety of the device during medical imaging procedures.
Recall #: Z-0327-2026
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.
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Sources: FDA iRES · Raw API Response
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