Change Healthcare Cardiology ECG Management System (2020-02-09)

Starting date:

February 9, 2020

Posting date:

March 13, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72533

Last updated: 2020-03-13

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  Reason
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  Affected products

Affected Products

Change Healthcare Cardiology ECG Management System

Reason

Users can view the ECG waveforms using either simultaneous or sequential ECG format options, depending on user configuration. By default, the simultaneous ECG format is presented on a scale of 25 mm/sec whereas in the sequential view the scale dynamically changes according to the resolution of the monitor in use.

Change Healthcare has identified 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.

Inaccurate estimation of the heart rate value may occur in instances where the user isestimating heart rate counting grid squares using the sequential ECG format. The user may assume that the ECG is presented on a scale of 25 mm/sec and thereby may inaccurately estimate the heart rate value.

Affected products