FDA Medical devices recall ·
The Pressio 2 ICP Monitoring System, Model Number PSO-4000 recall
- Recall number
- Z-1029-2026
- Date
- (initiated November 17, 2025)
- Company / brand
- Sophysa
Rue Sophie Germain, Besancon, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 105 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Why was it recalled?
Customer complaints of Pressio monitor rebooting.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 03760124132076, All monitors
Distribution
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
States: Arizona California Florida Idaho New Jersey Oklahoma Oregon Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1029-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.