Change Healthcare Cardiology Hemo 14.1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262100020), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 2, 2024Open, Classified

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

   Z-0958-2025 · Root cause: Software design · FDA record ↗

2. 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-0126-2025 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathFeb 20, 2020Computer Software Problem; Application Program Problem; Unintended Application Program Shut Down; Computer Software Problem; Application Program Problem; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE CATHETERIZATION LAB INVOLVING A PATIENT IN FULL CARDIAC ARREST UNDERGOING CPR, DEFIBRILLATION, AND ARTIFICIAL VENTILATION, THAT THE RT MONITOR WENT BLANK MULTIPLE TIMES AND REBOOTED FOR SEVERAL SECONDS AND RETURNED TO FULL FUNCTIONALITY. DURING THE PROCEDURE AND THE REPORTED RT MONITOR BLANKING OUT EVENTS, AS INDICATED IN THE DEVICE INSTRUCTIONS FOR USE AUXILIARY DEVICES WERE USED TO MONITOR THE PATIENT'S VITAL SIGNS. SUBSEQUENT TO THE PROCEDURE THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 9731301 ↗

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, Classified
  Change Healthcare Cardiology Hemo Software
• Z-0957-2025 · Dec 2, 2024 · Open, Classified
  McKesson Cardiology Hemo software
• Z-0128-2025 · Aug 21, 2024 · Open, Classified
  McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
• Z-1490-2019 · Mar 25, 2019 · Terminated
  McKesson Cardiology Hemo
• Z-1489-2019 · Mar 25, 2019 · Terminated
  Horizon Cardiology Hemo
• Z-2968-2018 · Mar 12, 2018 · Terminated
  McKesson 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 · Terminated
  McKesson 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 · Terminated
  McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, an