Class 2 Device Recall Sophysa

• Date Initiated by Firm: November 17, 2025
• Date Posted: January 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1029-2026
• Recall Event ID: 98073
• 510(K)Number: K162108
• Product Classification: Device, monitoring, intracranial pressure - Product Code GWM
• Product: The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
• Code Information: UDI/DI 03760124132076, All monitors
• FEI Number: 3001587388
• Recalling Firm/ Manufacturer: Sophysa; Rue Sophie Germain; Besancon France
• Manufacturer Reason for Recall: Customer complaints of Pressio monitor rebooting.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 105 units
• Distribution: US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GWM