Merge Cardio 12.0.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842000100768), received between Dec 29, 2020 and May 5, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (4 reports).

1 FDA recall record name this device's identifier, 1 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, 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-1401-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 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 WHEN USING THE MEASUREMENT TOOL TO MEASURE RIGHT VENTRICLE TAPE, IN M-MODE THAT THE DECIMAL PLACE IS SHIFTED CAUSING THE MEASUREMENT TO LOOK INCORRECT IN THE REPORT AND WORKSTATION. WORK BETWEEN MERGE HEALTHCARE AND THE CUSTOMER IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780292 ↗
• MalfunctionFeb 2, 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 1/15/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT THE LEFT ATRIAL INTERNAL DIAMETER MEASUREMENT WAS DISPLAYING INCORRECTLY ON THE CARDIO CLINICAL REPORT. THIS MAPPING STRING WAS UPDATED AND THE ISSUE WAS CONFIRMED TO BE RESOLVED. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269980 ↗
• MalfunctionDec 31, 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, AN INTERNAL INVESTIGATION REVEALED THAT DUE TO TWO MEASUREMENTS BEING MAPPED TO THE SAME CODE, ONE MEASUREMENT COULD OVERWRITE THE OTHER IN THE CLINICAL CARDIO REPORT. THE "MR FLOW RATE" MEASUREMENT AND THE "MAX VELOCITY (MR)" MEASUREMENT WERE BOTH MAPPED TO CPCODE (10607). INTERNAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101546 ↗
• MalfunctionDec 29, 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 E/E MEASUREMENT (THE RATIO BETWEEN EARLY MITRAL INFLOW VELOCITY AND MITRAL ANNULAR EARLY DIASTOLIC VELOCITY) WAS DISPLAYING INCORRECTLY ON THE CARDIO CLINICAL REPORT. THIS MAPPING STRING FOR E/E WAS UPDATED AND THE ISSUE WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11090973 ↗