FDA recall Z-0127-2025

Product

Horizon Cardiology Hemo. Version 12.2.

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

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

Key facts

Status

Ongoing

Initiation date

2024-08-21

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2025