Sophysa recalls all Pressio 2 ICP Monitoring Systems (Model PSO-400:00) due to customer complaints of monitor reboots. No immediate action needed but check for updates.
Customer complaints of Pressio monitor rebooting.
Sophysa is recalling all Pressio 2 ICP Monitoring Systems (Model PSO-4000) because customers report the monitor reboots. This could cause interruptions in critical medical monitoring.
The monitor reboots due to customer complaints, which may interrupt continuous intracranial pressure monitoring. This could lead to temporary gaps in critical patient data but does not pose an immediate safety risk.
Healthcare professionals using the Pressio 2 ICP monitor for intracranial pressure monitoring are affected. Patients receiving this monitoring are at risk if the monitor reboots frequently.
Check for the model number PSO-4000 on the device. The recall applies to all units sold by Sophysa.
Identify the model number on your Pressio 2 ICP monitor; it should be PSO-4000.
The recall is due to customer complaints of monitor reboots, which may cause temporary interruptions in monitoring but does not pose an immediate safety risk.
No immediate action is required, but you should check for updates from Sophysa if reboots continue.
Check the model number on your device; affected units are all Pressio 2 ICP monitors with model number PSO-4000.
We’ve drafted a message you can send Sophysa to request your refund or repair — edit it as you like.
Subject: Recall Z-1029-2026 — Sophysa Sophysa Hello, I own a Sophysa that is covered by recall Z-1029-2026 from Sophysa. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
