Medical device recalls Moderate risk

CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions software version 14.2.2

Recall date
August 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0030-2026
FDA classification
Class II
Brand / firm
CHANGE HEALTHCARE CANADA COMPANY
Sold / distributed
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.

Why it was recalled

Due to software issue, radiology reports may not be fully displayed when viewing.

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 Radiology Solutions software version 14.2.2

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