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Sources: EU EUDAMED, US FDA
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FDA Recall
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The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
FDA Recall
Open, Classified
·Product code GWM·April 9, 2024
The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
FDA Recall
Open, Classified
·Product code GWM·April 9, 2024
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
FDA Recall
Open, Classified
·Sophysa Rue Sophie Germain Besancon France·Product code GWM·November 17, 2025