Integra LifeSciences is recalling 78 units of the CUSA Clarity C7000 Console (Software Version 2.1.1.909), an ultrasonic surgical aspirator system used in neurosurgery. A software issue can cause the touch screen to become unresponsive, which may disrupt critical surgical procedures. While no injuries have been reported, this device is used in high-stakes medical environments and requires immediate attention.
The software defect renders the touch screen non-functional, preventing surgeons from adjusting settings or controlling the device during surgery. This could lead to surgical delays or the inability to safely complete a procedure.
Software Version: 2.1.1.909
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 ยท 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.