← FDA ENFORCEMENT
Z-1029-2026Class II
Sophysa
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Sophysa
Product type
Device
Status
Ongoing
Report date
2026-01-14
Distribution
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Product quantity
105 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Customer complaints of Pressio monitor rebooting.
Product description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Code / lot info
UDI/DI 03760124132076, All monitors
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →