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Recall Observatory FDA recall evidence

Device product

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Z-1029-2026

November 17, 2025

Class II

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

    reason.no_named_rule · v1.0.0

    Customer complaints of Pressio monitor rebooting.