Reported Jan 14, 2026 · Ongoing
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sophysa · Rue Sophie Germain · Besancon · N/A
Is this the product you have?
The Pressio 2 ICP Monitoring SystemModel Number PSO-4000Intracranial Pressure Monitor
- Lot codes and dates
- UDI/DI 03760124132076, All monitors
- Amount recalled
- 105 units
Where it was sold
Why it was recalled
Customer complaints of Pressio monitor rebooting.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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