Merge CardioRecalls & reported problems across all models

We found 6 models of Merge Cardio by Merge Healthcare Solutions Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Aug 12, 2018 and Mar 20, 2025 — classified as 1 death, 33 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (12 reports).

5 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Merge Cardio recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 19, 2025Open, 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 · names 3 of these models · Recall details · FDA record ↗

2. Feb 19, 2025Open, 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 ↗

3. Feb 19, 2025Open, 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 ↗

4. Feb 19, 2025Open, 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-1399-2025 · Root cause: Software design · Recall details · FDA record ↗

5. May 8, 2020Terminated

   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 · names 2 of these models · Recall details · FDA record ↗

Most reported Merge Cardio problems

Merge Cardio models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Merge Cardio 10.3

  System, Image Processing, Radiological
  2 recalls13 reports
• Merge Cardio 11.0

  System, Image Processing, Radiological
  2 recalls8 reports
• Merge Cardio 12.1

  System, Image Processing, Radiological
  1 recall1 death8 reports
• Merge Cardio 12.0.1

  System, Image Processing, Radiological
  1 recall4 reports
• Merge Cardio 12.2

  System, Image Processing, Radiological
  1 recall1 report
• Merge Cardio 12.4

  System, Image Processing, Radiological
  1 recall0 reports

Recent Merge Cardio adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionOct 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  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 10/20/2023, MERGE HEALTHCARE WAS NOTIFIED VIA EMAIL THAT A MEDICAL DEVICE REPORT (B)(4) CONCERNING OUR PRODUCT WAS SUBMITTED TO THE FDA VIA THE MEDWATCH PROGRAM. MERGE HEALTHCARE HAS BEEN IN CONTACT WITH THE CUSTOMER. A SERVICE CASE, (B)(4), WAS OPENED ON (B)(6) 2023. THE CUSTOMER ALLEGED THAT EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026719 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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