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Sophysa recalls
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Sophysa and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-01-14FDA-DeviceClass IIStop using Sophysa Pressio 2 ICP monitors
Sophysa's Pressio 2 ICP Monitoring System (Model PSO-4000) may unexpectedly reboot during use. This device is used in hospitals to measure pressure inside the skull. The reboots could interrupt critical monitoring of patients.
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