Change Healthcare Cardiology Hemo 15.0.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262100105), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 death.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

3 FDA recall records name this device's identifier, 3 still open.

7 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-2071-2025 · 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. 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.

• DeathJan 8, 2026Blocked Connection

  CHANGE HEALTHCARE (CHC) IS FILING THIS REPORT BECAUSE A PATIENT DEATH OCCURRED AT A CUSTOMER FACILITY; CHC'S INVESTIGATION, CONSISTENT WITH THE TREATING CLINICIAN'S ACCOUNT, DETERMINED THAT THE CHC CARDIOLOGY HEMO SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. EVENT SUMMARY: ON DEC 10TH 2025, DURING A SALES CALL WITH A U.S. CUSTOMER (B)(6), IT WAS REVEALED THAT AN ADVERSE EVENT OCCURRED ON (B)(6) WHILE THE HEMO SYSTEM WAS NOT RESPONDING. AT THE REQUEST OF CHC, THE CUSTOMER PROVIDED ADDITIONAL DETAILS AND THEIR INTERPRETATION OF THE CASE. THE PATIENT WAS A 75-YEAR-OLD WITH SEVERE CARDIAC HISTORY AND ARRIVED AT THE CUSTOMER FACILITY FOR A CORONARY INTERVENTION PROCEDURE. UPON ARRIVAL, THE PATIENT'S CONDITION DETERIORATED RAPIDLY. AN EMERGENCY HEART ATTACK WAS ACTIVATED; THE PATIENT WAS INTUBATED AND WAS ACTIVELY BEING RESUSCITATED. THE CUSTOMER INDICATED THAT THE PATIENT INFORMATION WAS NOT TRANSFERRING TO THE REAL TIME (RT) MONITOR, AND FOR APPROXIMATELY 40 MINUTES, VITAL SIGNS AND CARDIAC RHYTHM WERE UNAVAILABLE ON THE RT MONITOR. CHANGE HEALTHCARE CUSTOMER SUPPORT WAS CONTACTED, AND THE CHC REPRESENTATIVE WALKED THE CUSTOMER THROUGH REMOVING A FIREWALL THAT WAS DISRUPTIN

  Patient problems: Myocardial Infarction

  MAUDE report 24010403 ↗

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-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