McKesson Cardiology Hemo 14.0Recalls & 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
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 80010939050027), received between May 4, 2018 and Oct 31, 2018 — classified as 2 deaths.
2 FDA recall records name this device's identifier, 2 still open.
8 other recalls cover devices cleared under the same FDA submission (K131497); they may or may not involve this specific model.
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
- 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 ↗
- 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 ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Sudden Cardiac Death2
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131497. One submission often covers many models, so check the product and lot details in each record.
- Z-2071-2025 · May 22, 2025 · Open, ClassifiedChange Healthcare Cardiology Hemo Software
- Z-0958-2025 · Dec 2, 2024 · Open, ClassifiedChange Healthcare Cardiology Hemo software
- Z-0126-2025 · Aug 21, 2024 · Open, ClassifiedChange Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
- Z-1490-2019 · Mar 25, 2019 · TerminatedMcKesson Cardiology Hemo
- Z-1489-2019 · Mar 25, 2019 · TerminatedHorizon Cardiology Hemo
- Z-2968-2018 · Mar 12, 2018 · TerminatedMcKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/h
- Z-0042-2015 · Aug 27, 2014 · TerminatedMcKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
- Z-0093-2015 · Jun 25, 2014 · TerminatedMcKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, an
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- Xper Flex Cardio Physiomonitoring System FC 2010Philips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 deaths38 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
- Change Healthcare Cardiology Hemo 14.1.1Change Healthcare Israel Ltd · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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