FDA Enforcement
Class II
Ongoing
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Recall: Z-1029-2026
·
Reported January 14, 2026
Enforcement
- Recall Number
- Z-1029-2026
- Event ID
- 98073
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Sophysa
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- January 14, 2026
- Initiation Date
- November 17, 2025
- Classification Date
- January 8, 2026
- Address
- Rue Sophie Germain, Besancon, N/A, France
Description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason
Customer complaints of Pressio monitor rebooting.
Code Info
UDI/DI 03760124132076, All monitors
Distribution
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Quantity
105 units