Fujifilm Healthcare Americas Corporation is recalling 130 units of the FDR D-EVO2 (DR-ID 12XXSE) mobile x-ray system family. These devices contain a defect where the radiation exposure settings automatically reset to default adult chest imaging levels whenever the key switch is turned on. Additionally, any exposure adjustments made on the console while the key switch is in the off position will not be saved or reflected when the unit is powered up. This can result in patients receiving unintended radiation doses if the operator does not manually re-verify the settings after turning the device on. Consumers should contact Fujifilm for technical support and instructions.
The x-ray system may default to radiation levels intended for adult chest imaging even when used on different patient types, such as children. This poses a risk of over-exposure or under-exposure to radiation, which could lead to unnecessary health risks or poor diagnostic image quality.
Software correction or device update
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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