medical Class II Updated 2024-10-23

CHANGE HEALTHCARE CANADA COMPANY recalls McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/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.
View official government recall

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