The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reported: January 14, 2026 Initiated: November 17, 2025 #Z-1029-2026
Product Description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason for Recall
Customer complaints of Pressio monitor rebooting.
Details
- Recalling Firm
- Sophysa
- Units Affected
- 105 units
- Distribution
- US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
- Location
- Besancon
Frequently Asked Questions
What product was recalled? ▼
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor. Recalled by Sophysa. Units affected: 105 units.
Why was this product recalled? ▼
Customer complaints of Pressio monitor rebooting.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2026. Severity: Moderate. Recall number: Z-1029-2026.
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