Medical device recalls Moderate risk

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

Recall date
February 10, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1682-2020
FDA classification
Class II
Brand / firm
CHANGE HEALTHCARE CANADA COMPANY
Sold / distributed
Distribution US nationwide, Canada and the United Kingdom

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

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