The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 17, 2025 |
| Reported | January 14, 2026 |
| Recalling firm | Sophysa |
| Country / region | France US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ. |
Hazard
Customer complaints of Pressio monitor rebooting.
Affected products
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
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