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Sophysa recalls The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Recalled January 14, 2026 · FDA recall Z-1029-2026 · Sophysa
Hazard
Customer complaints of Pressio monitor rebooting. · FDA Class II
Units
105 units
Sold at
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Description
Customer complaints of Pressio monitor rebooting.
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Manufacturer(s)
Sophysa
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →