Medical device recalls Moderate risk

CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Cardiology Hemodynamics Software

Recall date
May 22, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2072-2025
FDA classification
Class II
Brand / firm
CHANGE HEALTHCARE CANADA COMPANY
Sold / distributed
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.

Why it was recalled

Due to complaints, software update may cause software to unexpectedly shutdown.

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

What was recalled

Change Healthcare Cardiology Hemodynamics Software

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