Reported Oct 23, 2024 · Ongoing
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Change Healthcare Canada Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CHANGE HEALTHCARE CANADA COMPANY · 10711 Cambie Rd Suite 130 · Richmond · N/A
Is this the product you have?
McKesson Cardiology Hemo. Versions 13.013.1.113.1.213.213.2.114.0
- Lot codes and dates
- 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
- Amount recalled
- 35 systems
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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