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Open, Classified

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

FDA Recall Z-1029-2026 · Posted 2026-01-08

Recalling FirmSophysa
Recall StatusOpen, Classified
Product CodeGWM
Date Initiated2025-11-17
Product Quantity105 units

Reason for Recall

Customer complaints of Pressio monitor rebooting.

Firm Action

Sophysa issued a Field Safety notice to its consignees on 11/25/2025 via email. The notice explained the issue and requested monitoring of the patient should the unintended reboot of the monitor occur. The consignees were directed to notify their sales representatives to schedule the monitor update.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162108Pressio 2 ICP Monitoring SystemSophysa SA · 2017-04-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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