FDA recall, , Moderate risk
Sophysa Pressio 2 ICP Monitoring System
The Pressio 2 ICP Monitoring System can reboot.
Summary by Recall Canary from the FDA notice
What happened
Sophysa, based in Besancon, France, recalled the Pressio 2 ICP Monitoring System, Model Number PSO-4000, an Intracranial Pressure Monitor, because of customer complaints of the Pressio monitor rebooting. The recall began on November 17, 2025, and was added to the FDA's Enforcement Report on January 8, 2026.
The product was distributed nationwide in the United States, including in Arizona, Wisconsin, Texas, Oregon, California, Oklahoma, Idaho, Florida, and New Jersey. The recall involved 105 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Pressio 2 ICP Monitoring System
- Model number
- PSO-4000
- UDI-DI
- 03760124132076
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, Wisconsin, Texas, Oregon, California, Oklahoma, Idaho, Florida, New Jersey.
- Company
- SophysaBesancon, France
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98073
- Recall number
- Z-1029-2026
- Quantity recalled
- 105 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
