⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Sophysa: The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Medical DevicesSource: FDA (device) · Date: 2026-01-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Sophysa
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason / hazard
Customer complaints of Pressio monitor rebooting.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Recall initiated
2025-11-17
Code info
UDI/DI 03760124132076, All monitors
Product quantity
105 units
Voluntary mandated
Voluntary: Firm initiated
City
Besancon
Country
France
Event id
98073
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