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McKesson Cardiology Hemo recallZ-0128-2025 · Change Healthcare Canada Company · initiated Aug 21, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Change Healthcare Canada Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Use error

What the company is doing

Change Healthcare notified consignees on about 08/21/2024 via emailed letter. Consignees were instructed to pay careful attention to the hemoglobin unit of measurement displayed on the top of the "results" screen of the Hemo application, communicate the issue to all relevant team members to ensure vigilance in data entry, ensure that the hemoglobin values are entered in the correct unit of measurement (mmol/l or g/dl) as configured in the Management Console and displayed at the top of the results screen, contact Change Healthcare support to schedule the deployment of the software update that addresses this issue. Additionally, consignees were requested to complete and return the response form. With regard to potentially affected data, Change Healthcare recommended consignees verify f the UOM setting for hemoglobin is configured to what users would expect, if the UOM settings are different than expected, contact Change Healthcare support for assistance with identifying when the UOM setting was changed, and which procedures were affected, and examine affected procedures and implement necessary corrective actions to rectify the data and address patient care concerns.

Recall details

Recall number
Z-0128-2025
Status
Open, Classified
Initiated by the company
Aug 21, 2024
Posted by the FDA
Oct 17, 2024
Recalling firm
Change Healthcare Canada Company
Quantity
35 systems
Product code
DQK
FDA submissions
K131497
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.

Product description

McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

Code information (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

8 devices cleared under K131497 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95284).

Sources and updates

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