Change Healthcare Cardiology HemoRecalls & reported problems across all models

We found 2 models of Change Healthcare Cardiology Hemo by Change Healthcare Israel Ltd in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 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

Change Healthcare 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.

1. Dec 2, 2024Class IIOpen, Classified

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

   Z-0958-2025 · 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-0126-2025 · Root cause: Use error · names 2 of these models · Recall details · FDA record ↗

Most reported Change Healthcare Cardiology Hemo problems

Change Healthcare Cardiology Hemo models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Change Healthcare Cardiology Hemo 14.1.1

  Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
  2 recalls1 death1 report
• Change Healthcare Cardiology Hemo 14.1

  Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
  1 recall0 reports

Recent Change Healthcare Cardiology Hemo adverse event reports

The 1 most recent reports across all models, 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 ↗