FDA-Device2025-07-09Class II
Change Healthcare Cardiology Hemodynamics Software
CHANGE HEALTHCARE CANADA COMPANY
Hazard
Due to complaints, software update may cause software to unexpectedly shutdown.
Sold states
Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
Affected count
4 systems
Manufactured in
10711 Cambie Rd Suite 130, Richmond, Canada
Products
Change Healthcare Cardiology Hemodynamics Software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2025Don't want to check this manually?
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