The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
This recall is currently active, issued January 8, 2026. It was issued by Sophysa Rue Sophie Germain Besancon France.
- Recall Initiated
- November 17, 2025
- Posted
- January 8, 2026
- Recall Number
- Z-1029-2026
- Quantity
- 105 units
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI/DI 03760124132076, All monitors
Root Cause
Software design
Action Taken
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.