Class II
Medical Device Recall: The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa · November 17, 2025
Reason for Recall
Customer complaints of Pressio monitor rebooting.
Distribution
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
States Affected
NATIONWIDE
Quantity Affected
105 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1029-2026
Status: ongoing
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