Z-0128-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- August 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 systems
Product Description
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
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 Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Code Information
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.