Change Healthcare Cardiology Hemo 14.2Recalls & reported problems

Change Healthcare Canada Company · Class 2

All models of Change Healthcare Cardiology Hemo (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262100037), received between Jun 17, 2021 and Jun 17, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Application Network 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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 ↗
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

Device problems

Application Network Problem1
Insufficient Device Problem Information1

Patient problems

Insufficient Information1

Recent adverse event reports

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

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 ↗

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

Device details

UDI-DI	`17540262100037`
Brand	Change Healthcare Cardiology Hemo
Model	14.2
Company	Change Healthcare Canada Company
Product code	MWI · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Class	Class 2
FDA submission	K131497
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Feb 13, 2023

Device type (GMDN): Cardiac catheterization laboratory computer

A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.

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All Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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