CHANGE HEALTHCARE CANADA COMPANY McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

Recommended Action

Per FDA guidance

Change Healthcare Canada Company notified customers on about 02/10/2020 via "Urgent Field Safety Notice" letter. Customers were informed of an issue whereby users who are estimating heart rate by counting grid squares, may assume that the Sequential ECG format is presented on a scale of 25 mm/sec and thereby may inaccurately estimate the heart rate value. Instructions included that the Simultaneous ECG format can be used rather than the Sequential ECG format, until the software is updated and the Sequential ECG format option can be used while maintaining awareness to the scale bar on the screen. Customers were also instructed to contact their users and train them on how to verify the ECG format mode they are working on and how they can change it. The notice needs to be distributed to all those within their organization who need to be aware and to please alert other parties affiliated with your organization that are affected by this field safety notice. Additionally, customers were informed that Change Healthcare is developing a software update that will enable presentation of the Sequential ECG format view using the 25 mm/sec scale and were requested to contact Change Healthcare Customer Support to: 1) Acknowledge they have read and understood this Urgent Field Safety Notice and 2) Arrange installation of software update/upgrade. Change Healthcare Customer Support contacts: - US / Canada: 1 866-777-0202 - UK / Ireland: +44 (0) 208 9527399