FDA-Device2020-04-15Class II
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE CANADA COMPANY
Hazard
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
Sold states
Distribution US nationwide, Canada and the United Kingdom
Affected count
51 units
Manufactured in
10711 Cambie Rd Suite 130, N/A, Richmond, British Columbia, Canada
Products
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2020Don't want to check this manually?
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