Reported Apr 15, 2020 · Ongoing

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

Change Healthcare Canada Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CHANGE HEALTHCARE CANADA COMPANY · 10711 Cambie Rd Suite 130 · Richmond, British Columbia · N/A

Is this the product you have?

  • McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Lot codes and dates
  • 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
Amount recalled
51 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.