Merge Cardio 12.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842000100928), received between Mar 23, 2022 and Mar 20, 2025 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 other recalls cover devices cleared under the same FDA submission (K051649); 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. Feb 19, 2025Class IIOpen, Classified

   When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

   Z-1402-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 02/19/2025, A CUSTOMER CONTACTED MERGE HEALTHCARE FOR ASSISTANCE WITH MERGE CARDIO'S STUDY LIST FILTERS. MERGE TECHNICAL SUPPORT REMOTELY CONNECTED TO THE CUSTOMER'S SYSTEM TO ASSIST WITH FILTER QUESTIONS. THE CUSTOMER WAS ATTEMPTING TO LOCATE A ECHOCARDIOGRAM PATIENT STUDY PERFORMED ON (B)(6) 20

  Patient problems: Insufficient Information; Unspecified Heart Problem

  MAUDE report 21656629 ↗
• MalfunctionJun 23, 2023Computer Software Problem; Computer Software Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON (B)(6) 2023, A CUSTOMER CONTACTED MERGE HEALTHCARE ALLEGING THAT SOME MITRAL VALVE MEASUREMENTS, IMPORTED INTO MERGE CARDIO FROM A 3RD PARTY TOOL, WERE SHOWING A DIFFERENT UNIT OF MEASUREMENT THAN THE MEASUREMENT UNITS IN MERGE CARDIO. WORK IS ONGOING BETWEEN THE CUSTOMER AND MERGE HEALTHCARE. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195030 ↗
• MalfunctionNov 29, 2022Computer Software Problem; Use of Device Problem; Application Program Problem; Computer Software Problem; Use of Device Problem; Application Program Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 11/01//2022, A PACS APPLICATION ADMINISTRATOR CONTACTED MERGE HEALTHCARE ALLEGING THAT SOMETIMES A DIFFERENT PATIENT'S INFO APPEARS UNEXPECTEDLY WHEN UTILIZING THREE DIFFERENT SYSTEMS (EPIC, MERGE CARDIO AND TOMTEC) AT THE SAME TIME. ACCORDING TO THE PACS ADMINISTRATOR, THIS CAN HAPPEN WHEN A USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15881783 ↗
• MalfunctionJul 28, 2022Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 06/30/2022 A TECHNOLOGIST CONTACTED MERGE HELATHCARE ALLEGING THAT THE SIMPSON'S BIPLANE MEASUREMENT IS INCORRECT ON MERGE CARDIO VERSION 12.1.1. WORK IS ONGOING BETWEEN THE CUSTOMER AND MERGE HEALTHCARE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN FURTHER INFORMATION BECOMES AVAILABLE. THIS HAS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123249 ↗
• MalfunctionJul 20, 2022Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON (B)(6) 2022, AN INTERNAL MERGE CARDIO TRAINER RECEIVED FEEDBACK FROM A USER WHO NOTICED DIFFERENCES BETWEEN THE MEASUREMENT TOOL NOMENCLATURE AND THE PATIENT REPORT. THE ISSUE IS BEING INVESTIGATED AND WORK IS ONGOING BETWEEN THE CUSTOMER AND MERGE HEALTHCARE. A SUPPLEMENTAL REPORT WILL BE FILED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065231 ↗
• MalfunctionJun 8, 2022Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 05/12/2022, AN INTERNAL CLINICAL CONTENT REPORTING ENGINEER FOUND AN INCORRECTLY MAPPED MEASUREMENT DURING A TRAINING SESSION FOR MERGE CARDIO VERSION 12.1.1. THE CUSTOMER REQUESTED LEFT ATRIA AND VENTRICLE VOLUME MEASUREMENTS TO BE CONFIGURED ON MERGE CARDIO REPORTS. THE CUSTOMER ALLEGED THAT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640351 ↗
• MalfunctionJun 6, 2022Application Program Problem; Application Program Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY-TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 05/09/2022, AN INTERNAL CLINICAL CONTENT REPORTING ENGINEER FOUND AN INCORRECTLY MAPPED MEASUREMENT DURING A TRAINING SESSION FOR MERGE CARDIO VERSION 12.1.1. THE CUSTOMER REQUESTED LEFT ATRIA AND VENTRICLE VOLUME MEASUREMENTS TO BE CONFIGURED ON MERGE CARDIO REPORTS. THE CUSTOMER ALLEGED THAT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606048 ↗
• MalfunctionMar 23, 2022Application Program Problem; Application Program Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION FROM MERGE HEALTHCARE AND OTHER VENDORS SYSTEMS INCLUDING IMAGES, HEMODYNAMIC STUDIES AND REPORTS, MEASUREMENTS (VIA IMPORT FROM DICOM STRUCTURED REPORTING, TEXT FILES OR OPTICAL CHARACTER RECOGNITION OF MEASUREMENTS CAPTURED ON IMAGES) AND CARDIOLOGY SIGNAL (WAVEFORM) DATA. MERGE CARDIO IS INTENDED TO ALLOW USERS TO REVIEW DIAGNOSTIC AND NON-DIAGNOSTIC QUALITY IMAGES, ANNOTATE STUDIES, PERFORM DIGITAL SUBTRACTION ON IMAGES, TO PERFORM QUANTITATIVE MEASUREMENTS ON IMAGES (INCLUDING BUT NOT LIMITED TO QUANTITATIVE CORONARY ANALYSIS, LEFT VENTRICULAR ANALYSIS, TIME, AREA, LENGTH, VELOCITY, ANGLE, VOLUME, AND VELOCITY TIME INTEGRALS), TO GENERATE PHYSICIAN GENERATED CLINICAL REPORTS (VIA STRUCTURE REPORTING AND TEMPLATE BASED TOOLS), AND TO STORE THIS INFORMATION IN A DATABASE. ON 02/24/2022, AN INTERNAL CLINICAL REPORTING SPECIALIST FOUND AN INCORRECTLY MAPPED MEASUREMENT DURING AN UPGRADE TO MERGE CARDIO VERSION 12.1.1. THE CUSTOMER REQUESTED HEPATIC VEIN MEASUREMENTS TO BE CONFIGURED ON MERGE CARDIO REPORTS. IT WAS FOUND THAT THE HEPATIC VEIN DIASTOLIC PEAK VELOCITY DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864771 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051649. One submission often covers many models, so check the product and lot details in each record.

• Z-1399-2025 · Feb 19, 2025 · Open, Classified
  VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information
• Z-1401-2025 · Feb 19, 2025 · Open, Classified
  VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture
• Z-1400-2025 · Feb 19, 2025 · Open, Classified
  VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system cl
• Z-1398-2025 · Feb 19, 2025 · Open, Classified
  VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture arch
• Z-2403-2020 · May 8, 2020 · Terminated
  Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used t
• Z-2123-2017 · Apr 13, 2016 · Terminated
  Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
• Z-1403-2017 · Apr 4, 2016 · Terminated
  Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Z-1415-2017 · Apr 4, 2016 · Terminated
  Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
• Z-1486-2017 · Apr 4, 2016 · Terminated
  Merge Cardio software.
• Z-0729-2017 · Mar 28, 2016 · Terminated
  Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies an
• Z-1046-2017 · Mar 28, 2016 · Terminated
  Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodyn
• Z-2709-2016 · Feb 9, 2016 · Terminated
  Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
• Z-2865-2016 · Jan 30, 2016 · Terminated
  Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
• Z-0555-2016 · Oct 26, 2015 · Terminated
  Merge Cardio with software version 10.1 LA.
• Z-0730-2017 · Oct 1, 2015 · Terminated
  Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors system

…and 2 more.