FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
- Recall number
- Z-0128-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2024-08-21
- Posted
- 2024-10-17
- Terminated
- not on file
- Reason
- 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.
- 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
- 35 systems
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K131497"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3003757840
- Firm city
- Richmond
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28