FDA Recall
Open, Classified
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Recall: Z-1029-2026
·
Initiated November 17, 2025
Recall
- Recall Number
- Z-1029-2026
- Event Number
- 98073
- Firm
- Sophysa Rue Sophie Germain Besancon France
- FEI Number
- 3001587388
- Product Code
- GWM
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- November 17, 2025
- Posted
- January 8, 2026
Description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason
Customer complaints of Pressio monitor rebooting.
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.
Distribution
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Quantity
105 units