Sophysa recalls The Pressio 2 ICP Monitoring System
- Recalling company
- Sophysa
- Product
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Reason
- Customer complaints of Pressio monitor rebooting.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 17, 2025
- Reported
- Jan 14, 2026
- Distribution
- US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
- Status
- Ongoing
- Quantity
- 105 units
- Lot / codes
- UDI/DI 03760124132076, All monitors
- Company location
- Besancon
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1029-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1029-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.