FDAClass IIJanuary 22, 2025

McKesson Cardiology Hemo software recall: Software Issue

McKesson Cardiology Hemo software

Why was McKesson Cardiology Hemo software recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software versions: 13.1.2/No UDI, 13.2.1/UDI:(01)80010939050010, 14/(01)80010939050027,

Product
McKesson Cardiology Hemo software
Recalling firm
A L I Technologies Ltd
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 date
January 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls