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.
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.
Recall #: Z-2071-2025; Quantity: 29 systems
Recall #: Z-2072-2025; Quantity: 4 systems
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.
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.