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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Change Healthcare Cardiology Software Recalled for Unexpected Shutdown

Agency Publication Date: July 2, 2025
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Summary

This recall affects 33 systems running Change Healthcare Cardiology Hemo and Hemodynamics software. Following consumer complaints, it was discovered that a software update may cause the program to shut down unexpectedly during clinical use. Change Healthcare Canada Company is initiating this voluntary recall to address versions 14.3.2 and 15.0.1 of the monitoring software.

Risk

The software may stop working suddenly and without warning. This could lead to delays in medical procedures or the loss of critical patient data during cardiology hemodynamic monitoring sessions.

What You Should Do

  1. The recalled products are Change Healthcare Cardiology Hemo Software (versions 14.3.2 and 15.0.1) and Change Healthcare Cardiology Hemodynamics Software (version 15.0.1).
  2. Check your system configuration to identify if your software matches UDI codes (01)17540262100051, (01)17540262100105, or (01)17540262100129. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Change Healthcare Cardiology Hemo Software
Variants: Version 14.3.2, Version 15.0.1
Model / REF:
14.3.2
15.0.1
UDI:
(01)17540262100051
(01)17540262100105

Recall #: Z-2071-2025; Quantity: 29 systems

Product: Change Healthcare Cardiology Hemodynamics Software
Variants: Version 15.0.1
Model / REF:
15.0.1
UDI:
(01)17540262100129

Recall #: Z-2072-2025; Quantity: 4 systems

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97046
Status: Active
Manufacturer: CHANGE HEALTHCARE CANADA COMPANY
Sold By: Hospitals; Healthcare Facilities; Cardiology Clinics
Manufactured In: Canada
Units Affected: 2 products (29 systems; 4 systems)
Distributed To: Alabama, Arkansas, California, Florida, Kentucky, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.