Health Products

Change Healthcare Cardiology Hemo/Hemodynamics™

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Change Healthcare Cardiology Hemo/Hemodynamics™
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Change Healthcare Cardiology Hemo/Hemodynamics™Not applicable.14.3.2
VERSION 15.0.1

Issue

A recent software modification introduced to enhance application stability inadvertently caused unintended regressions in the user experience. The modification was designed to provide a robust solution for dealing with applications freezes. While this approach aimed to improve overall system reliability and stability, it has led to isolated scenarios where the application aborts unexpectedly during specific workflows. In the Change Healthcare Cardiology Hemo product, this regression manifests as localized failures of the Hemo Infosystem application during certain workflows. These occurrences are limited to specific use cases and do not affect the broader functionality of the product. The real time monitor continues to operate and provide patient monitoring information to the user. Recall start date: May 22, 2025

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