The Pressio 2 ICP Monitoring System, Model Number PSO-400... (Sophysa Rue Sophie Germain Besancon France) – customer complaints of pressio monito... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Brand
Sophysa Rue Sophie Germain Besancon France
Lot Codes / Batch Numbers
UDI/DI 03760124132076, All monitors
Products Sold
UDI/DI 03760124132076, All monitors
Sophysa Rue Sophie Germain Besancon France is recalling The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor due to Customer complaints of Pressio monitor rebooting.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customer complaints of Pressio monitor rebooting.
Recommended Action
Per FDA guidance
Sophysa issued a Field Safety notice to its consignees on 11/25/2025 via email. The notice explained the issue and requested monitoring of the patient should the unintended reboot of the monitor occur. The consignees were directed to notify their sales representatives to schedule the monitor update.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026