The Pressio 2 ICP Monitoring System, Model Number PSO-4000 recallZ-1029-2026 · Sophysa · initiated Nov 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sophysa or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Customer complaints of Pressio monitor rebooting.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1029-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2025
- Posted by the FDA
- Jan 8, 2026
- Recalling firm
- Sophysa
- Quantity
- 105 units
- Product code
- GWM
- FDA submissions
- K162108
- Distribution
- US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Product description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Code information (models, lots, serial numbers)
UDI/DI 03760124132076, All monitors
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sophysa PSO-4000Sophysa · DEVICE, MONITORING, INTRACRANIAL PRESSURE1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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