FDA Recall: Software update may cause software to unexpectedly shutdown

Company: Change Healthcare Canada Company
Date of Enforcement Report: 7/2/2025
Class: II

PRODUCT

Change Healthcare Cardiology Hemo Software

Recall Number:

Z-2071-2025

REASON:

Due to complaints, software update may cause software to unexpectedly shutdown.

RECALLING FIRM/MANUFACTURER:

Change Healthcare Canada Company

VOLUME:

29 systems

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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