FUJIFILM Healthcare Americas Corporation is recalling 16 units of the FDR Visionary Suite (Model CH-200) X-ray high-voltage generator. A defect in the internal electrical contacts can cause the system to continue receiving power even after it has been turned off, leading to overheating and potential damage to surrounding parts. This defect can also cause the device to emit smoke. The recall affect units distributed across eight U.S. states.
The electrical contacts inside the generator cabinet may weld together, preventing the power supply from cutting off. This continuous current can cause the circuit to overheat, damaging the equipment and posing a fire or smoke inhalation risk to patients and staff.
The quantity of units is 16; Serial numbers are listed for each specific version variant.
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.