Health product recall

Change Healthcare Cardiology Hemo/Hemodynamics™

Last updated

Summary

Product
Change Healthcare Cardiology Hemo/Hemodynamics™
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Change Healthcare Canada Company

10711 Cambie Road, Richmond, British Columbia, Canada, V6X 3G5

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77558

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