FDA Medical Device Recalls (openFDA)
Sophysa: The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Recall number
- Z-1029-2026
- Recalling firm
- Sophysa
- Product
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Status
- Open, Classified
- Initiated
- 2025-11-17
- Posted
- 2026-01-08
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 03760124132076, All monitors
- 510(k) numbers
- K162108
- PMA numbers
- not on file
- Product code
- GWM
- Firm FEI
- 3001587388
- Firm city
- Besancon
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28