Intracranial pressure monitors recalled after customer complaints of rebooting
Sophysa is recalling 105 Pressio 2 ICP Monitoring Systems following customer complaints of the Pressio monitor rebooting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites complaints of the monitor rebooting with no stated consequence or reported harm.
Plain-English summary
The Pressio 2 ICP Monitoring System, model number PSO-4000, an intracranial pressure monitor, is being recalled by Sophysa.
The reason given in the enforcement record is customer complaints of the Pressio monitor rebooting.
The record lists 105 units carrying UDI/DI 03760124132076, covering all monitors. Distribution was nationwide in the United States, in Arizona, Wisconsin, Texas, Oregon, California, Oklahoma, Idaho, Florida and New Jersey. The FDA has classified the action as Class II.
The record describes a rebooting monitor and states no further consequence or reported injuries. Facilities should follow Sophysa's instructions.
The recalled product
- Product
- The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Manufacturer
- Sophysa
- Hazard
- Affected units
- 105
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
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