Change Healthcare Cardiology Hemo 15.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262100129), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

4 FDA recall records name this device's identifier, 4 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

1. May 22, 2025Class IIOpen, Classified

   Due to complaints, software update may cause software to unexpectedly shutdown.

   Z-2072-2025 · Root cause: Software design · Recall details · FDA record ↗

2. 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 ↗

3. Dec 2, 2024Class IIOpen, Classified

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

   Z-0959-2025 · Root cause: Software design · Recall details · FDA record ↗

4. 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 · Recall details · 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.

• MalfunctionJul 26, 2024Human-Device Interface Problem; Inadequate User Interface; Human-Device Interface Problem; Inadequate User Interface

  CHANGE HEALTHCARE CARDIOLOGY HEMODYNAMICS PROVIDES HEMODYNAMIC CALCULATIONS AND FORMULAS. THE SETTINGS, SUCH AS UNIT OF MEASUREMENT (UOM), FOR THESE FORMULAS AND CALCULATIONS ARE CONFIGURED IN THE CHANGE HEALTHCARE MANAGEMENT CONSOLE (CHMC) AND ARE DESIGNATED BY THE SITE ACCORDING TO FACILITY STANDARDS. IN THIS EVENT, THE UOM FOR THE HEMOGLOBIN VALUE, USED AS PART OF THE HEMODYNAMICS FORMULAS, WAS CONFIGURED IN THE CHMC AS MMOL/L (MILLIMOLES/LITER). HOWEVER, THE CLINICAL STAFF CONTINUED TO MANUALLY ENTER THE HEMOGLOBIN VALUE AS G/DL (GRAMS/DECILITER) WITHOUT BEING AWARE OF THE CHANGED CONFIGURATION FOR THE UOM. NO ADVERSE HEATH CONSEQUENCES RESULTING FROM THIS ISSUE WERE REPORTED TO CHANGE HEALTHCARE.

  Patient problems: Insufficient Information

  MAUDE report 19844346 ↗

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