Class IIReported 2026-01-14

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

Recalled by Sophysa

Reason for Recall

Customer complaints of Pressio monitor rebooting.

Recall Number

Z-1029-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-17

Reported

2026-01-14

Distribution

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

Code Info

UDI/DI 03760124132076, All monitors

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.