Change Healthcare Cardiology HemoRecalls & reported problems across all models

We found 6 models of Change Healthcare Cardiology Hemo by Change Healthcare Canada Company in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2021 and Jan 8, 2026 — classified as 2 deaths, 1 malfunction.

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

5 FDA recall records name at least one of these models by its device identifier, 5 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. 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. May 22, 2025Class IIOpen, Classified

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

   Z-2071-2025 · Root cause: Software design · names 2 of these models · 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. 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 · names 5 of these models · Recall details · FDA record ↗

5. 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 6 of these models · Recall details · FDA record ↗

Most reported Change Healthcare Cardiology Hemo problems

Change Healthcare Cardiology Hemo models

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

• Change Healthcare Cardiology Hemo 15.1

  Computer, Diagnostic, Programmable
  4 recalls1 report
• Change Healthcare Cardiology Hemo 15.0.1

  Computer, Diagnostic, Programmable
  3 recalls1 death1 report
• Change Healthcare Cardiology Hemo 14.3.2

  Computer, Diagnostic, Programmable
  3 recalls0 reports
• Change Healthcare Cardiology Hemo 14.2

  Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
  2 recalls1 death1 report
• Change Healthcare Cardiology Hemo 14.3

  Computer, Diagnostic, Programmable
  2 recalls0 reports
• Change Healthcare Cardiology Hemo 15.0

  Computer, Diagnostic, Programmable
  1 recall0 reports

Recent Change Healthcare Cardiology Hemo adverse event reports

The 3 most recent reports across all models, 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 ↗
• 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 ↗
• DeathJun 17, 2021Application Network Problem; Insufficient Device Problem Information; Application Network Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN EMERGENCY STEMI PROCEDURE IN THE CATHERIZATION LAB INVOLVING A PATIENT IN CRITICAL STATE, THE CONTROL PANEL ON THE INFOSYSTEM'S APPLICATION WAS GREYED OUT AND AS A RESULT, THE USERS WERE NOT ABLE TO CONTROL THE RT MONITOR OR TAKE HEMODYNAMIC SAMPLES USING THE INFOSYSTEM. THE USER DID NOT USE THE RT MONITOR KEYPAD WHICH ALLOWS CONTROL OVER THE RT MONITOR DISPLAY WHEN THE CONTROL PANEL OF THE INFOSYSTEM IS GREYED OUT, AS INDICATED IN THE CHANGE HEALTHCARE HEMO USER GUIDE. THE PATIENT WAS THEN MOVED TO A DIFFERENT LAB WHERE THE PROCEDURE WAS COMPLETED. SUBSEQUENT TO THE PROCEDURE THE PATIENT EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ALSO CONNECTED TO ANAESTHESIA EQUIPMENT WHICH ALLOWED AUXILIARY MONITORING OF THE PATIENT'S VITALS SIGNS.

  Patient problems: Insufficient Information

  MAUDE report 12018365 ↗

Other Change Healthcare Canada Company products

• Change Healthcare Radiology Solutions2 models · 1 reports · 3 recalls
• McKesson Cardiology Hemo2 models · 2 reports · 2 recalls