FDAAugust 21, 2024device
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
change healthcare canadachangechange healthcare
UPCs
1754026210001317540262100020175402621000371754026210004417540262100051175402621000991754026210010517540262100129
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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