The Recall Desk
HighFDA (Devices)·Z-0126-2025·Announced 2024-10-23

Change Healthcare Cardiology Hemodynamic Software Calculation Error Recall

Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving software that calculates critical clinical parameters. Configuration and data-entry errors can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This risk-of-harm scenario warrants a High severity rating under the FDA Class II classification.

Plain-English summary

Change Healthcare Cardiology Hemo is a cardiology hemodynamic analysis system used for patient assessment. The recall affects versions 14.1.1, 14.2, 14.3, 14.3.2, 15.0.1, and 15.1. Approximately 221 systems have been distributed worldwide, including in the United States, Australia, Canada, Germany, Ireland, Israel, and the United Kingdom.

The issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the user's understanding. This configuration mismatch can lead to incorrect data entry and subsequent inaccurate hemodynamic calculations.

Inaccurate hemodynamic calculations may result in misdiagnosis and inappropriate treatment.

The recalled product

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.
Manufacturer
CHANGE HEALTHCARE CANADA COMPANY
Category
Medical Device — Cardiology / Hemodynamic Analysis
Hazard
  • data-entry-error
  • calculation-error
  • configuration-error
  • misdiagnosis-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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
  • 15.0.1
  • 15.1.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category