The Pressio 2 ICP Monitoring System — Class II medical device recall Z-1029-2026
Ongoing recall by Sophysa, reported 2026-01-14, distributed nationwide. Customer complaints of Pressio monitor rebooting.
| Recall number | Z-1029-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sophysa, Besancon, France |
| Recall initiated | 2025-11-17 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 105 units |
| UPC / GTIN / UDI-DI | 03760124132076 |
| Model numbers | PSO-4000 |
Product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason for recall
Customer complaints of Pressio monitor rebooting.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1029-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.