Canon Medical System, USA, INC. has recalled 8 units of its digital radiography/fluoroscopy system used for diagnostic and interventional angiography. A software issue in the SPOT Fluoro program causes the collimator to return to an incorrect default position when acquisition programs are changed. This results in the X-ray area being partially covered by a static image instead of showing the intended area.
The software defect causes the collimator blades to move to a default position that may be larger than specified, leaving the active X-ray area obscured by a static image. This can interfere with medical procedures and diagnostic visualization.
System is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
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.