[Recalled] McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management — Inaccurate estimation of the heart rate may occur in instances where the user i… | FDA 2020-02-10

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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

This Class II recall concerns device products distributed in Canada and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from CHANGE HEALTHCARE CANADA COMPANY

• Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. — Class II
• Change Healthcare Cardiology Hemodynamics Software — Class II
• Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS. — Class II
• Change Healthcare Radiology Solutions software version 14.2.2 — Class II
• Change Healthcare Enterprise Viewer — Class II
• Horizon Cardiology Hemo. Version 12.2. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.