Health & Personal Care
HIGH
FDA DEVICE
Sophysa Recalls Pressio 2 ICP Monitoring System Due to Rebooting Hazard
Sophysa recalled 105 units of the Pressio 2 ICP Monitoring System on November 17, 2025, after receiving customer complaints regarding unexpected rebooting. This defect poses a high risk for patients relying on the device for monitoring intracranial pressure. Users should stop using the device immediately and follow the manufacturer's instructions.
Sophysa
Customer complaints