FDA-Device2026-01-14Class II
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
Hazard
Customer complaints of Pressio monitor rebooting.
Sold states
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Affected count
105 units
Manufactured in
Rue Sophie Germain, Besancon, France
Products
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2026Don't want to check this manually?
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