Recall Z-0126-2025— CHANGE HEALTHCARE CANADA COMPANY

Name: FDA recall Z-0126-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-21

Class II · Ongoing

Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2024-08-21. It names one FDA 510(k) clearance: K131497. Product: Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.. Reason: 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..

Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Classification: Class II
Status: Ongoing
Initiated: 2024-08-21
Firm location: Richmond, Canada

510(k) clearances named in this recall

1 on FDA's record

K131497 — MCKESSON CARDIOLOGY HEMOMckesson Israel , Ltd.·cleared 2013-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.