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Lower risk Medical device recall · FDA · Published February 10, 2020

Change Healthcare ECG Software: Inaccurate Heart Rate Estimation Risk

Change Healthcare recalls specific ECG management software versions due to potential inaccurate heart rate estimation when using grid squares in Sequential ECG format. Affected users should check their software version and contact support.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1682-2020Medical deviceChange Healthcare ›
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Contact the company

Recalling firmCHANGE HEALTHCARE CANADA COMPANY10711 Cambie Rd Suite 130 · Richmond, British Columbia, Canada
✎ GovInfoNow plain-language explainer

Change Healthcare recalls certain versions of their ECG management software because users might miscount heart rate squares in the Sequential ECG format, leading to inaccurate readings. This could affect medical decisions if not corrected. Read more at govinfonow.com/recall/65862-change-healthcare-ecg-software-inaccurate-heart-rate-estimation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65862-change-healthcare-ecg-software-inaccurate-heart-rate-estimation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1682-2020

Cite this page

“Change Healthcare ECG Software: Inaccurate Heart Rate Estimation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65862-change-healthcare-ecg-software-inaccurate-heart-rate-estimation-risk. Based on FDA recall #Z-1682-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1682-2020%22&limit=1).

The FDA announced on Feb. 10, 2020, that Change Healthcare Canada Company is recalling McKesson and Change Healthcare Cardiology ECG Management software due to inaccurate heart rate estimation hazards. The agency issued recall number Z-1682-2020 for the Class II device.

How to tell if you have it

  • 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

The hazard

According to the FDA, inaccurate estimation of the heart rate may occur when users estimate heart rate by counting grid squares using the Sequential ECG format.

Context

GovInfoNow's records show Change Healthcare Canada Company has eight other recalls on record since Aug. 25, 2020. Other recent recalls of similar products include Midmark IQecg ECG Software Error: Incorrect Heart Rate Readings (July 20, 2026), Philips Cardiac Workstation 5000: Inaccurate Heart Rate Data Risk (July 1, 2026), and GE Medical Systems ECG Systems Software Error Risks Patient Data Mix-Up (April 21, 2026).

How to tell if you have this one

Check your software version against the listed versions: McKesson Cardiology 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2 for McKesson Cardiology, and 14.1.1, 14.2 for Change Healthcare.

  • Brand
    Change Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Identify your software version by checking the product details or documentation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution US nationwide, Canada and the United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Feb 10, 202012. FDA classified it Class II: Apr 8, 202023. Published in FDA’s Enforcement Report: Apr 15, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1682-2020 (February 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1682-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA