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 is designed for monitoring intracranial pressure in patients, primarily used in hospitals and clinical settings. It is critical for managing patients with conditions affecting brain pressure.
The rebooting issue in the Pressio monitor can cause loss of monitoring capabilities, potentially compromising patient safety. This defect may lead to delayed responses in critical situations.
This recall is not part of a broader industry pattern.
Patients and healthcare providers need to act quickly to prevent risks associated with the monitor's malfunction. The urgency is high, as improper monitoring can have severe health implications.
The model number can typically be found on the device's label or in the user manual.
Expect a response for refunds or replacements within 4-6 weeks after contacting Sophysa.
Keep records of all communications with the manufacturer, including emails, phone calls, and any receipts related to the purchase.
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.
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