Class II — Sophysa
| Recalling firm | SOPHYSA |
|---|---|
| Registered facility | SOPHYSA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Customer complaints of Pressio monitor rebooting. |
| Product | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor |
| Quantity | 105 units |
| Distribution | US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ. |
| Initiated | 2025-11-17 |
| Classified | 2026-01-08 |
| Recall number | Z-1029-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sophysa (Z-1029-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98073/
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