🔍 RecallPedia

Horizon Cardiology Hemo. Version 12.2.

Class I - Dangerous
🏥 Medical Devices Recalled: August 21, 2024 CHANGE HEALTHCARE CANADA COMPANY Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    No UDI. Version 12.2
  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:
CHANGE HEALTHCARE CANADA COMPANY
Reason for Recall:
A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Horizon Cardiology Hemo. Version 12.2.

Product Codes/Lot Numbers:

No UDI. Version 12.2

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0127-2025

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