FDA Device recall Z-1029-2026
The Pressio 2 ICP Monitoring System, Model Number PSO-4000
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of The Pressio 2 ICP Monitoring System, Model Number PSO-4000 by Sophysa, citing customer complaints of Pressio monitor rebooting.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1029-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-17 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Sophysa |
| Distribution | US |
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason
Customer complaints of Pressio monitor rebooting.
Identifiers
| code_info | UDI/DI 03760124132076, All monitors |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1029-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.