FDAHealthNovember 17, 2025
Sophysa — The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
⚠️ Customer complaints of Pressio monitor rebooting.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 17, 2025
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
What's affected?
- Product
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Brand
- Sophysa
- Lot code
- UDI/DI 03760124132076, All monitors
Additional details
UDI/DI 03760124132076, All monitors
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 105 units.
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