Sophysa recalled 105 units of the Pressio 2 ICP Monitoring System on November 17, 2025, after receiving customer complaints regarding unexpected rebooting. This defect poses a high risk for patients relying on the device for monitoring intracranial pressure. Users should stop using the device immediately and follow the manufacturer's instructions.
Customer complaints of Pressio monitor rebooting.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Sophysa or your healthcare provider for instructions
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The Pressio 2 ICP Monitoring System, Model Number PSO-4000, is designed for monitoring intracranial pressure. It was distributed nationwide in states including Arizona, Wisconsin, Texas, Oregon, California, Oklahoma, Idaho, Florida, and New Jersey.
The Pressio monitor has been reported to reboot unexpectedly, which can lead to a loss of vital monitoring data. This malfunction increases the risk of serious health consequences for patients.
The recall stems from customer complaints regarding the rebooting issue. No specific injury or death counts have been reported.
Stop using the Pressio 2 ICP Monitoring System immediately. Contact Sophysa or your healthcare provider for further instructions regarding the recall.
For questions or concerns, reach out to Sophysa directly. More information can be found at the FDA recall page linked above.
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