A L I Technologies Ltd recalls Change Healthcare Cardiology Hemodynamics software
- Recall date
- December 2, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0959-2025
- 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
Change Healthcare Cardiology Hemodynamics software
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