Class II

Medical Device Recall: Change Healthcare Cardiology Hemo software

A L I Technologies Ltd · December 2, 2024

Reason for Recall

Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.

States Affected

NATIONWIDE

Quantity Affected

204 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0958-2025

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.