Z-1029-2026Class II

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Name: Z-1029-2026 The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Creator: Sophysa
Published: 2025-11-17
License: https://open.fda.gov/license/

Sophysa / initiated 2025-11-17 / Open, Classified / root cause: software

FDA source

Sophysa began a recall of The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor on 2025-11-17. FDA classified it as Class II and gives the reason as "Customer complaints of Pressio monitor rebooting". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1029-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-17
Posted: 2026-01-08
Recalling firm: Sophysa
Product: The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: Customer complaints of Pressio monitor rebooting.
Root cause tag: software
FDA 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 in commerce: 105 units
Distribution: US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Product codes and lots: UDI/DI 03760124132076, All monitors

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1029-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1029-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-08

Product code GWM

K162108Class IIPressio 2 ICP Monitoring SystemSophysa SA / cleared 2017-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)