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.
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. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom. Quantity: 221 systems Lot/code info: UDI Numbers: (01)17540262100013(10)140100, (01)17540262100020(10)140101, (01)17540262100037(10)140200, (01)17540262100044(10)140300, (01)17540262100051(10)140302, (01)17540262100099(10)150000, (01)17540262100105(10)150001, (01)17540262100129(10)150100. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
17540262100013, 17540262100020, 17540262100037, 17540262100044, 17540262100051, 17540262100099, 17540262100105, 17540262100129
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.