Z-1029-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- November 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105 units
Product Description
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Reason for Recall
Customer complaints of Pressio monitor rebooting.
Distribution Pattern
US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Code Information
UDI/DI 03760124132076, All monitors