Change Healthcare Cardiology ECG Management 14.1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262110029), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K113515); 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.

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.

• MalfunctionFeb 20, 2020Computer Software Problem; Computer Software Problem

  THE ECG WAVEFORMS GRID SCALE, IN THE SPECIFIC "SEQUENTIAL' CONFIGURATION IS DYNAMICALLY CHANGED BASED ON THE SCREEN RESOLUTION IN USE. THEREFORE, THE ECG WAVEFORMS MAY BE DISPLAYED USING OTHER SCALES RATHER THAN 25MM/SEC. THE ON-SCREEN SCALE BAR CORRECTLY INDICATES THE ACTUAL SCALE USED FOR THE DISPLAY, AND THE HEART RATE VALUE AS SENT FROM THE CART/ CALCULATED BY THE SYSTEM IS CLEARLY DISPLAYED ON THE SCREEN AND IS NOT AFFECTED BY THE ISSUE. IN ADDITION, THE SEQUENTIAL LAYOUT USED IN THE ECG PDF REPORT IS DISPLAYED IN THE 25 MM/SEC SCALE. THE ISSUE WAS REPORTED DURING AN ECG MANAGEMENT IMPLEMENTATION BY THE CUSTOMER, PRIOR TO USING THE DEVICE IN CLINICAL USE. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 9731293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113515. One submission often covers many models, so check the product and lot details in each record.

• Z-1682-2020 · Feb 10, 2020 · Open, Classified
  McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
• Z-0910-2015 · Dec 19, 2014 · Terminated
  McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult a