FDA Device recall Z-0128-2025
McKesson Cardiology Hemo
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of McKesson Cardiology Hemo by Change Healthcare Canada, citing A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in mis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0128-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-21 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Change Healthcare Canada |
| Distribution | US |
Product
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0128-2025%22
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