McKesson Cardiology HemoRecalls & reported problems across all models
Change Healthcare Canada Company · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one McKesson Cardiology Hemo model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of McKesson Cardiology Hemo by Change Healthcare Canada Company in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 4, 2018 and Oct 31, 2018 — classified as 2 deaths.
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
McKesson Cardiology Hemo recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 2, 2024Open, Classified
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Z-0957-2025 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Aug 21, 2024Open, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported McKesson Cardiology Hemo problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Sudden Cardiac Death2
McKesson Cardiology Hemo models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- McKesson Cardiology Hemo 14.0Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- McKesson Cardiology Hemo 13.2.1Computer, Diagnostic, Programmable2 recalls0 reports
Recent McKesson Cardiology Hemo adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTING FACILITY INFORMED CHANGE HEALTHCARE THAT THE MCKESSON CARDIOLOGY HEMO APPLICATION APPEARED TO BE UNRESPONSIVE UPON EXITING A CASE IN THE SYSTEM FOLLOWING COMPLETION OF A PATIENT PROCEDURE. DURING THE PROCEDURE AND BEFORE EXITING THE CASE, THE PATIENT EXPIRED.
Patient problems: Sudden Cardiac Death
MAUDE report 8022584 ↗DeathMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTING FACILITY CONTACTED CHANGE HEALTHCARE TO ASSIST IN AN INVESTIGATION INTO MCKESSON CARDIOLOGY HEMO - PHYSIOLOGICAL ALARMS DEACTIVATION INVOLVING A PATIENT DEATH.
Patient problems: Sudden Cardiac Death
MAUDE report 7488292 ↗
Other Change Healthcare Canada Company products
All Change Healthcare Canada Company devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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