| 2025-11-17 |
Class II
|
Ongoing |
Z-1029-2026 |
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor |
— |
Customer complaints of Pressio monitor rebooting. |
| 2024-04-09 |
Class II
|
Ongoing |
Z-1826-2024 |
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial… |
— |
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during impl… |
| 2024-04-09 |
Class II
|
Ongoing |
Z-1825-2024 |
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial… |
— |
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during impl… |