Sophysa Recalls

1 recall found for Sophysa. Check if any of your products are affected.

HIGHFDA DEVICE

Nov 17, 2025

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

Brand Statistics

Total Recalls

Pages