The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
FDA device recall Z-1029-2026 · posted 2026-01-08 · Open, Classified
Recall details
- Recalling firm
- Sophysa
- Reason for recall
- Customer complaints of Pressio monitor rebooting.
- Action taken
- Sophysa issued a Field Safety notice to its consignees on 11/25/2025 via email. The notice explained the issue and requested monitoring of the patient should the unintended reboot of the monitor occur. The consignees were directed to notify their sales representatives to schedule the monitor update.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- GWM
- Quantity affected
- 105 units
- Distribution
- US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
- Date initiated
- 2025-11-17
- Date posted
- 2026-01-08
- Location
- Besancon, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Pressio 2 ICP Monitoring System (K162108) | Sophysa SA | 2017-04-17 |