Device product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Z-1029-2026
Product summary
- Firm
- Sophysa
- Event
- Event 98073
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 105 units
- Official record key
device-enforcement:Z-1029-2026
Official wording
Reason: Customer complaints of Pressio monitor rebooting.
Code information: UDI/DI 03760124132076, All monitors
Distribution pattern: US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.
Derived failure modes
-
Unknown
Customer complaints of Pressio monitor rebooting.