Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Pressio 2 ICP Monitoring System Recalled by Sophysa Due to Customer complaints of Pressio monitor rebooting.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sophysa directly.
Affected Products
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Quantity: 105 units
Why Was This Recalled?
Customer complaints of Pressio monitor rebooting.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sophysa
Sophysa has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report