Recall Z-1029-2026 ยท GWM Device, Monitoring, Intracranial Pressure
Sophysa
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
| Date | Jan 8, 2026 (initiated Nov 17, 2025) |
| Status | Open, Classified |
| Reason | Customer complaints of Pressio monitor rebooting. |
| Root cause | Software design |
| Action | Sophysa issued a Field Safety notice to its consignees on 11/25/2025 via email. The notice explained the issue and requested monitoring of the patient should the unintended reboot of the monitor occur. The consignees were directed to notify their sales representatives to schedule the monitor update. |
| Quantity | 105 units |
| Distribution | US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162108 | Pressio 2 ICP Monitoring System Sophysa SA, Apr 17, 2017 |