Drug recall
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
FDA recall event 98073 · Class II · Sophysa
Key facts
| Event ID | 98073 |
|---|---|
| Recall numbers | Z-1029-2026 |
| Recalling firm | Sophysa |
| Product type | Devices |
| Products | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customer complaints of Pressio monitor rebooting. |
| Initiation date | Nov 17, 2025 |
| Report date | Jan 14, 2026 |
| City | Besancon |
| Country | France |
| FEI number | 3001587388 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: