Z-0128-2025Class II

McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0

Name: Z-0128-2025 McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0
Creator: Change Healthcare Canada Company
Published: 2024-08-21
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2024-08-21 / Open, Classified

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0 on 2024-08-21. FDA classified it as Class II and gives the reason as "A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0128-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-21
Posted: 2024-10-17
Recalling firm: Change Healthcare Canada Company
Product: McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
FDA root cause: Use error
Action: Change Healthcare notified consignees on about 08/21/2024 via emailed letter. Consignees were instructed to pay careful attention to the hemoglobin unit of measurement displayed on the top of the "results" screen of the Hemo application, communicate the issue to all relevant team members to ensure vigilance in data entry, ensure that the hemoglobin values are entered in the correct unit of measurement (mmol/l or g/dl) as configured in the Management Console and displayed at the top of the results screen, contact Change Healthcare support to schedule the deployment of the software update that addresses this issue. Additionally, consignees were requested to complete and return the response form. With regard to potentially affected data, Change Healthcare recommended consignees verify f the UOM setting for hemoglobin is configured to what users would expect, if the UOM settings are different than expected, contact Change Healthcare support for assistance with identifying when the UOM setting was changed, and which procedures were affected, and examine affected procedures and implement necessary corrective actions to rectify the data and address patient care concerns.
Quantity in commerce: 35 systems
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Product codes and lots: UDI Numbers: (01)80010939050010(10)130201, (01)80010939050027(10)140000. Versions Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0127-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0128-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17

Product code DQK

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)