Z-0957-2025Class II

McKesson Cardiology Hemo software

Name: Z-0957-2025 McKesson Cardiology Hemo software
Creator: A L I Technologies Ltd
Published: 2024-12-02
License: https://open.fda.gov/license/

A L I Technologies Ltd / initiated 2024-12-02 / Open, Classified / root cause: software

FDA source

A L I Technologies Ltd began a recall of McKesson Cardiology Hemo software on 2024-12-02. FDA classified it as Class II and gives the reason as "Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0957-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-02
Posted: 2025-01-16
Recalling firm: A L I Technologies Ltd
Product: McKesson Cardiology Hemo software
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Root cause tag: software
FDA root cause: Software design
Action: On December 2, 2024 Change Healthcare Canada Company issued a "Urgent Field Safety" Recall Notice to affected consignees. Change Healthcare Canada Company ask consignees to take the following actions: 1. Please contact and work with our Customer Support team to identify and correct any potentially affected data. 2. This notice must be distributed to all personnel within your organization who need to be aware of this Urgent Field Safety Notice. Customers should alert other affiliated parties that may be affected by this Urgent Field Safety Notice. 3. To ensure effectiveness of any required corrective actions, please maintain awareness of this Urgent Field Safety Notice until the issue has been fully resolved. 4. Please notify our Customer Support department that you have read and understood this field safety notice, and if you want the product update to be installed on your system. Customer Support number by region: US / Canada: 1 877 654 4366 5. Once again, until the product update is installed at your site, Change Healthcare recommends that the immediate actions (described above) be taken.
Quantity in commerce: 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.
Product codes and lots: Software versions: 13.1.2/No UDI, 13.2.1/UDI:(01)80010939050010, 14/(01)80010939050027.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0957-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16
Z-0958-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16
Z-0959-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code MWI

K131497Class IIMckesson Cardiology HemoMckesson Israel , Ltd. / cleared 2013-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)