Sophysa recalls The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Recall date

November 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1029-2026

FDA classification

Class II

Brand / firm

Sophysa

Sold / distributed

US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.

Why it was recalled

Customer complaints of Pressio monitor rebooting.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor