Sophysa: Device Recall
Recall #Z-1029-2026 · 11/17/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1029-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Sophysa
- Status
- Ongoing
- Date Initiated
- 11/17/2025
- Location
- Besancon, France
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105 units
Reason for Recall
Customer complaints of Pressio monitor rebooting.
Product Description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Distribution Pattern
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.