Z-1029-2026 Class II Ongoing
FDA device recall Z-1029-2026 was initiated by Sophysa on November 17, 2025 and is designated Class II. Reason for recall: Customer complaints of Pressio monitor rebooting. The recall status is ongoing. Affected quantity: 105 units.
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