FDA recall Z-1029-2026

Sophysa · Class II · device

Product

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

Reason for recall

Customer complaints of Pressio monitor rebooting.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-11-17
Report date: 2026-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Besancon, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2026