🔍 RecallPedia

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Class I - Dangerous
🏥 Medical Devices Recalled: February 10, 2020 CHANGE HEALTHCARE CANADA COMPANY Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2; Change Healthcare Software Versions: 14.1.1, 14.2
  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:
Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Product Codes/Lot Numbers:

McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2; Change Healthcare Software Versions: 14.1.1, 14.2

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1682-2020

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