🔍 RecallPedia

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

Class I - Dangerous
🏥 Medical Devices Recalled: November 7, 2014 Breas Medical AB Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
  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:
Breas Medical AB
Reason for Recall:
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

Product Codes/Lot Numbers:

All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2094-2015