CHANGE HEALTHCARE CANADA COMPANY: Medical Device Recall in 2024 - (Recall #: Z-0126-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 21, 2024

Date Posted: October 23, 2024

Recall Number: Z-0126-2025

Event ID: 95284

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.

Status: Ongoing

Product Quantity: 221 systems

Code Information:

UDI Numbers: (01)17540262100013(10)140100, (01)17540262100020(10)140101, (01)17540262100037(10)140200, (01)17540262100044(10)140300, (01)17540262100051(10)140302, (01)17540262100099(10)150000, (01)17540262100105(10)150001, (01)17540262100129(10)150100. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated