Change Healthcare has recalled 259 Cardiology Hemo systems, including Change Healthcare, Horizon, and McKesson branded versions, due to a software configuration issue. This defect involves the unit of measurement (UOM) for hemoglobin, which can lead to incorrect data entry and inaccurate hemodynamic calculations during cardiac procedures. While no specific injuries were mentioned, these errors can result in an incorrect diagnosis and potentially dangerous medical treatments.
The software configuration may cause users to enter hemoglobin data in a unit of measurement that the system interprets differently, leading to inaccurate calculations of blood flow and heart function. These errors can cause healthcare providers to misdiagnose a patient's condition or provide inappropriate medical treatments based on faulty data.
Manufacturer Notification and Support
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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