Medical device recalls Moderate risk

A L I Technologies Ltd recalls McKesson Cardiology Hemo software

Recall date
December 2, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0957-2025
FDA classification
Class II
Brand / firm
A L I Technologies Ltd
Sold / distributed
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.

Why it was recalled

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

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

What was recalled

McKesson Cardiology Hemo software

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