United StatesThe Pressio 2 Intracranial Pressure Monitoring System (Model PSO-4000; UDI/DI 03760124132076; all monitors, 105 units) distributed in AZ, WI, TX, OR, CA, OK, ID, FL and NJ is affected. Sophysa is recalling the monitors after customer complaints that the Pressio monitor reboots during use.
What's being recalled
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Recalling firm: Sophysa, Besancon, France.
How to identify it
UDI/DI 03760124132076, All monitors
The hazard
Customer complaints of Pressio monitor rebooting.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)