Agency classClass IIOur severity:High FDA (Devices)·Z-0128-2025·Announced 2024-10-23

Change Healthcare Cardiology Hemo Software Recalled for Calculation Errors

Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall involves a risk-of-harm product (medical software) where injury or misdiagnosis has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.

Plain-English summary

Change Healthcare Canada Company is recalling 35 systems of McKesson Cardiology Hemo software, including versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, and 14.0. The recall is due to a potential issue where incorrect data entry can lead to inaccurate hemodynamic calculations.

The issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the user's understanding. This discrepancy can potentially result in misdiagnosis and inappropriate treatment for patients.

The affected software was distributed worldwide, including in the United States, Australia, Canada, Germany, Ireland, Israel, and the United Kingdom. Users of the affected software versions should contact Change Healthcare for further instructions on how to resolve the configuration issue.

The recalled product

Product: McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Manufacturer: CHANGE HEALTHCARE CANADA COMPANY
Category: Medical Device — Software
Hazard: misdiagnosis
inaccurate-calculation
Affected units: 35

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 (7)

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

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by CHANGE HEALTHCARE CANADA COMPANY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · CHANGE HEALTHCARE CANADA COMPANY

See all →

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Same hazard · misdiagnosis