🔍 RecallPedia

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Class I - Dangerous
🏥 Medical Devices Recalled: May 8, 2018 Human Design Medical Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    Pending
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Human Design Medical Llc
Reason for Recall:
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation

Product Codes/Lot Numbers:

Pending

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2530-2018