Pressio 2 ICP Monitor Recalled for Unexpected Rebooting
Sophysa is recalling 105 units of the Pressio 2 ICP Monitoring System due to customer complaints of unexpected rebooting. The malfunction could interrupt critical patient monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with reported complaints of unexpected rebooting. Because the device performs a critical safety function in patient monitoring, unexpected shutdowns constitute a risk-of-harm condition even without reported injuries.
Plain-English summary
Sophysa is recalling the Pressio 2 ICP Monitoring System (Model PSO-4000), an intracranial pressure monitor used in neurosurgical procedures and critical care. The recall affects 105 units distributed nationwide across nine states: Arizona, Wisconsin, Texas, Oregon, California, Oklahoma, Idaho, Florida, and New Jersey.
The recall was initiated due to customer complaints of the monitors rebooting unexpectedly.
Healthcare facilities and providers affected by this recall should contact Sophysa for information regarding remedies or replacement.
The recalled product
- Product
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Manufacturer
- Sophysa
- Hazard
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 03760124132076
- All monitors
Distribution
Distributed nationwide across the United States.
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