The Pressio 2 ICP Monitoring System recall (Sophysa)
Medical deviceClass IIOngoing
Summary: Sophysa is recalling The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor. Reason: Customer complaints of Pressio monitor rebooting.
What is being recalled
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Why
Customer complaints of Pressio monitor rebooting.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ. (states named: Arizona, California, Florida, Idaho, New Jersey, Oklahoma, Oregon, Texas, Wisconsin)
How to tell if yours is affected
UDI/DI 03760124132076, All monitors
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1029-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 17, 2025 |
| Reported | January 14, 2026 |
| Company | Sophysa |
| Company location | Besancon, France |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 105 units |
More recalls from Sophysa · all medical device recalls · recalls from November 2025