FDA-Device2025-01-22Class II
Change Healthcare Cardiology Hemo software
A L I Technologies Ltd
Hazard
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Sold states
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.
Affected count
204 units
Manufactured in
3700 Gilmore Way Suite 207, Burnaby, Canada
Products
Change Healthcare Cardiology Hemo software
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2025Don't want to check this manually?
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