Recall Z-1029-2026— Sophysa

Name: FDA recall Z-1029-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-17

Class II · Ongoing

Class II FDA medical device recall by Sophysa, initiated 2025-11-17. It names one FDA 510(k) clearance: K162108. Product: The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor. Reason: Customer complaints of Pressio monitor rebooting..

Recalling firm: Sophysa
Classification: Class II
Status: Ongoing
Initiated: 2025-11-17
Firm location: Besancon, France

510(k) clearances named in this recall

1 on FDA's record

K162108 — Pressio 2 ICP Monitoring SystemSophysa SA·cleared 2017-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Customer complaints of Pressio monitor rebooting.

Data sourced from openFDA. This site is unofficial and independent of the FDA.