Merge Cardio 11.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842000100416), received between Nov 29, 2018 and Dec 29, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (5 reports).

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

15 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-1400-2025 · Root cause: Software design · Recall details · FDA record ↗

2. May 8, 2020Class IITerminated

   An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.

   Z-2403-2020 · Root cause: Software Design Change · 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.

• MalfunctionDec 29, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  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 12/7//2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT THE RIGHT VENTRICULAR SYSTOLIC (RV S) MEASUREMENT WAS MAPPED INCORRECTLY. MERGE HEALTHCARE TECHNICAL SUPPORT WAS ABLE TO WORK WITH THE CUSTOMER TO REMAP THE MEASUREMENT AND CONFIRMED THAT IT WAS DISPLAYING CORRECTLY. NO FURTHER ACTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114872 ↗
• MalfunctionOct 21, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT THE BULLET END DIASTOLIC AREA MEASUREMENT WAS MAPPED INCORRECTLY. MERGE HEALTHCARE TECHNICAL SUPPORT WAS ABLE TO WORK WITH THE CUSTOMER TO REMAP THE MEASUREMENT AND CONFIRMED THAT IT WAS DISPLAYING CORRECTLY. NO FURTHER ACTION IS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675598 ↗
• MalfunctionApr 6, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT PREND VMAX WAS MAPPED TO PR PEAK VELOCITY AND SHOULD BE MAPPED TO PR PEAK IN END DIASTOLE AND THAT PREND PG WAS MAPPED TO PR PEAK GRADIENT AND SHOULD BE MAPPED TO PR GRADIENT IN END DIASTOLE. WORK BETWEEN MERGE HEALTHCARE AND THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624283 ↗
• MalfunctionSep 8, 2020Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  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) 2020, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT THE MITRAL REGURG PISA RADIUS WAS MAPPED INCORRECTLY. UPON INVESTIGATION AND TROUBLESHOOTING BY MERGE HEALTHCARE SUPPORT, THE MEASUREMENT WAS REMOVED AND REMAPPED. IT WAS CONFIRMED TO THEM BE MAPPED CORRECTLY IN THE CUSTOMER'S SYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10504706 ↗
• MalfunctionJan 10, 2020Application Program Problem: Parameter Calculation Error; Data Problem; Application Program Problem: Parameter Calculation Error; Data Problem

  INDICATIONS FOR USE: 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. MERGE CARDIO IS SOFTWARE COMPRISED OF MODULES THAT PERFORM UNDER STANDARD "OFF THE SHELF" PERSONAL COMPUTERS AND SERVERS RUNNING THE MICROSOFT WINDOWS 2000/2003/XP OPERATING SYSTEMS. MERGE CARDIO IS IMAGE DATA STORAGE AND DISPLAY SOFTWARE THAT ACCEPTS DICOM (DIGITAL IMAGING AND

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9578382 ↗
• MalfunctionFeb 19, 2019Data Problem; Data Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION 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. ON (B)(6) 2019, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT DIAGNOSTIC MEASUREMENT TAKEN BY THEIR MODALITY WAS INCORRECT AND NEEDED TO BE DISABLED. DUE TO AN INCORRECT VALUES DISPLAYING IN THE DIAGNOSTIC REPORT, THERE IS A POTENTIAL FOR INCORRECT TREATMENT OF A PATIENT THAT COULD RESULT IN HARM. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350142 ↗
• MalfunctionFeb 18, 2019Data Problem; Data Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION 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. ON (B)(6) 2019, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT DIAGNOSTIC MEASUREMENT TAKEN BY THEIR MODALITY WAS INCORRECT AND NEEDED TO BE DISABLED. DUE TO AN INCORRECT VALUES DISPLAYING IN THE DIAGNOSTIC REPORT, THERE IS A POTENTIAL FOR INCORRECT TREATMENT OF A PATIENT THAT COULD RESULT IN HARM. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348342 ↗
• MalfunctionNov 29, 2018Data Problem; Data Problem

  MERGE CARDIO IS A SYSTEM INTENDED TO BE USED TO ACQUIRE, STORE, PRINT, TRANSFER, AND ARCHIVE CLINICAL INFORMATION 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. ON (B)(4) 2018, IT WAS FOUND INTERNALLY WHILE PATCHING THE CUSTOMERS 3.5 REPORTING KNOWLEDGE BASE TO 5.0 REPORTING KNOWLEDGE BASE THAT SOME OF THE MICHIGAN Z-SCORES WERE CALCULATING INCORRECTLY. THIS IS DUE TO THE FORMULA USING 'B' VS 'BSA' FOR BODY SURFACE AREA. THIS VARIABLE HAS BEEN CAUSING Z-SCORES TO CALCULATE INCORRECTLY. DUE TO AN INCORRECT VALUE DISPLAYING IN THE DIAGNOSTIC REPORT, THERE IS A POTENTIAL FOR INCORRECT TREATMENT OF A PATIENT THAT COULD RESULT IN HARM. HOWEVER AT THIS TIME, THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS ISSUE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8114058 ↗

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-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-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-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-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-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-1403-2017 · Apr 4, 2016 · Terminated
  Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
• 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
• Z-1517-2017 · Sep 22, 2015 · 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-1496-2017 · Sep 22, 2015 · Terminated
  Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.