Sophysa recalls
2 official recalls and safety alerts involving Sophysa since 2024-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Sophysa or the relevant agency.
- 2026-01-14
USSophysa recalls The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
FDA · DeviceSophysaUS Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.Official notice →- 2024-05-22
- US
Sophysa S.A. recalls The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular…
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient.…
FDA · DeviceSophysa S.A.Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the…Official notice →