Focalyx Technologies, LLC. has recalled 18 units of its Focalyx Fusion software, an accessory used in image-guided prostate biopsy and treatment procedures. The software may not function properly when used with Windows 10, potentially leading to equipment malfunctions during clinical use. Because this software guides interventional and diagnostic procedures, these issues could result in patient harm during a biopsy or significant delays in treatment and therapy.
Accessories within the software may fail to operate correctly on Windows 10, which can cause inaccuracy or device failure during prostate procedures, potentially leading to physical injury or delayed medical care.
Software accessory for image-guided prostate procedures.
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.