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McKesson Cardiology Hemo 13.2.1Recalls & reported problems

Change Healthcare Canada Company · Class 2

All models of McKesson Cardiology Hemo (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Dec 2, 2024Class IIOpen, Classified

    Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

    Z-0957-2025 · Root cause: Software design · Recall details · FDA record ↗

  2. Aug 21, 2024Class IIOpen, Classified

    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.

    Z-0128-2025 · Root cause: Use error · Recall details · FDA record ↗

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Sources and updates

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