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Lower risk Medical device recall · FDA · Published August 21, 2024

Change Healthcare Canada Horizon Cardiology Hemo Version 12.2 Recall: Inaccurate

Change Healthcare Canada recalls Horizon Cardiology Hemo Version : Incorrect hemoglobin unit settings may cause inaccurate blood pressure readings, risking misdiagnosis. Affected units have specific model numbers.

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

🇺🇸 FDA recall #Z-0127-2025Medical deviceChange Healthcare Canada ›
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Contact the company

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

Change Healthcare Canada is recalling Horizon Cardiology Hemo software version 12.2 because it can display incorrect hemoglobin measurements. This might lead to wrong diagnoses or treatments if users misinterpret the unit settings. Read more at govinfonow.com/recall/54186-change-healthcare-canada-horizon-cardiology-hemo-version-12-2-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/54186-change-healthcare-canada-horizon-cardiology-hemo-version-12-2-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0127-2025

Cite this page

“Change Healthcare Canada Horizon Cardiology Hemo Version 12.2 Recall: Inaccurate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54186-change-healthcare-canada-horizon-cardiology-hemo-version-12-2-recall. Based on FDA recall #Z-0127-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0127-2025%22&limit=1).

The FDA announced on August 21, 2024, that Change Healthcare Canada Company is recalling its Horizon Cardiology Hemo. Version 12.2 device. The recall addresses a potential for incorrect data entry leading to inaccurate hemodynamic calculations.

How to tell if you have it

  • Brand: Change Healthcare Canada
  • Product: Horizon Cardiology Hemo. Version 12.2
  • Description: No UDI. Version 12.2
  • Quantity: 3 systems

The hazard

According to the FDA, incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement for hemoglobin is configured differently from the user's understanding.

Context

GovInfoNow's records show Change Healthcare Canada Company has had 8 other recalls since February 10, 2020. Recent brand recalls include a May 22, 2025 software update that may cause unexpected shutdowns and an August 13, 2025 radiology software issue where reports may not display correctly. Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter System Recall: Patient Data Mismatch Risk (July 29, 2026) and Nova Biomedical StatStrip Glucose Meter Software Issue Causes Patient Data Errors (July 29, 2026).

How to tell if you have this one

Check for Horizon Cardiology Hemo software version 12.2. The product has no UDI (Unique Device Identification) and was sold under the manufacturer's name.

  • Brand
    Change Healthcare Canada
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-0126-2025Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.; UDI Numbers: (01)17540262100013(10)140100, (01)17540262100020(10)140101, (01)17540262100037(10)140200, (01)17540262100044(10)140300, (01)17540262100051(10)140302, (01)17540262100099(10)150000, (01)17540262100105(10)150001, (01)17540262100129(10)150100. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.221 systems
Z-0127-2025Horizon Cardiology Hemo. Version 12.2.; No UDI. Version 12.23 systems
Z-0128-2025McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.; UDI Numbers: (01)80010939050010(10)130201, (01)80010939050027(10)140000. Versions Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.35 systems
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your Horizon Cardiology Hemo software version is 12.2 to determine if it's affected.

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: “Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, 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: Aug 21, 202412. FDA classified it Class II: Oct 17, 202423. Published in FDA’s Enforcement Report: Oct 23, 202432024
  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-0127-2025 (August 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0127-2025 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