Sophysa has recalled 105 units of the Pressio 2 ICP Monitoring System (Model PSO-4000), a device used for monitoring intracranial pressure. The recall was issued following customer reports that the monitor may unexpectedly reboot during operation. If you are using this device, you should contact Sophysa or your medical equipment distributor to arrange for a return, replacement, or correction of the system.
The monitor can unexpectedly reboot while in use, which causes a temporary loss of intracranial pressure data. This interruption in critical monitoring could delay necessary medical interventions for patients with elevated brain pressure, potentially leading to serious complications.
All monitors affected.
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.