Class II

Medical Device Recall: Change Healthcare Cardiology Hemodynamics Software

CHANGE HEALTHCARE CANADA COMPANY · May 22, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

4 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2072-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.