FDANovember 17, 2025device
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Customer complaints of Pressio monitor rebooting.
What to do
FDA enforcement status: Ongoing
Brands named
sophysa
UPCs
03760124132076
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAThe 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-VT2024-04-09
- FDAThe 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/Cata...2024-04-09
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