FDA Medical Device · Z-0957-2025

McKesson Cardiology Hemo software

Class II · Ongoing

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

Affected lots / codes — check yours against thisSoftware versions: 13.1.2/No UDI, 13.2.1/UDI:(01)80010939050010, 14/(01)80010939050027,

Recalling firm: A L I Technologies Ltd, Burnaby,
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 1 unit
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.
Recall initiated: December 2, 2024
Classified: January 16, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0957-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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