The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 03760124132076, All monitors
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sophysa
- Reason for Recall:
- Customer complaints of Pressio monitor rebooting.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Product Codes/Lot Numbers:
UDI/DI 03760124132076, All monitors
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1029-2026