FDA-Device2026-01-14Class IIPROCESSING DEFECT
Sophysa Pressio 2 ICP Monitoring System recalled for unexpected reboots
What this means
Sophysa's Pressio 2 ICP Monitoring System (Model PSO-4000) may unexpectedly reboot during use. This device is used in hospitals to measure pressure inside the skull. The reboots could interrupt critical monitoring of patients.
- If you operate or maintain a Pressio 2 ICP monitor (Model PSO-4000), stop using it immediately.
- Contact Sophysa or your hospital's biomedical team for guidance on replacement or repair.
- Check if your facility received one of the 105 affected units distributed in AZ, WI, TX, OR, CA, OK, ID, FL, or NJ.
The agency's original wording
Hazard
Customer complaints of Pressio monitor rebooting.
Intended for
Adults
Illnesses reported
None reported
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-1029-2026Want us to check the next one for you?
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