FDA DevicesClass II
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressur...
Published: January 14, 2026Recall ID: Z-1029-2026Category: devicesCountry: US
Reason for Recall / Hazard
Customer complaints of Pressio monitor rebooting.
Product Description & Identification
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Additional Source Details
| Field | Value |
|---|---|
| City | Besancon |
| Event id | 98073 |
| Address 1 | Rue Sophie Germain |
| Code info | UDI/DI 03760124132076, All monitors |
| Postal code | N/A |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 105 units |
| Reason for recall | Customer complaints of Pressio monitor rebooting. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251117 |
| Center classification date | 20260108 |
Overview
- Recalling FirmSophysa
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.