Besancon, France
Sophysa recalls
1 recall recorded since 2018, most recently on 17 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 November 2025
- Reason
- Customer complaints of Pressio monitor rebooting.
- Distribution
- US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1029-2026
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.