FDA Medical devices recall ·
McKesson Cardiology Hemo recall
- Recall number
- Z-0128-2025
- Date
- (initiated August 21, 2024)
- Company / brand
- Change Healthcare Canada Company
10711 Cambie Rd Suite 130, Richmond, Canada - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0128-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.