Merge Cardio V11.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00842000100751), received between Jan 3, 2020 and Jun 29, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (7 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 16, 2026.

Recalls naming this device

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

2. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Computer 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) 2022, A CUSTOMER CONTACTED MERGE HEALTHCARE ALLEGING THAT THREE MEASUREMENTS, COMING FROM THEIR IMAGING MODALITY, WERE SHOWING A DIFFERENT UNIT OF MEASUREMENT THAN THE MEASUREMENT UNITS IN MERGE CARDIO. MERGE HEALTHCARE TECHNICAL SUPPORT WAS ABLE TO WORK WITH THE CUSTOMER REGARDING THE ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14850225 ↗
• MalfunctionJun 16, 2022Computer 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) 2022, A CUSTOMER CONTACTED MERGE HEALTHCARE ALLEGING THAT THEIR IMAGING MODALITY WAS SHOWING A DIFFERENT UNIT OF MEASUREMENT THAN THE AV VTI MEASUREMENT IN MERGE CARDIO. MERGE HEALTHCARE TECHNICAL SUPPORT WAS ABLE TO WORK WITH THE CUSTOMER REGARDING THE ALLEGED ISSUE. IT WAS DETERMINED THA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712830 ↗
• MalfunctionOct 18, 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 LVOT DIAMETER 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 NECESSARY AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651792 ↗
• MalfunctionSep 24, 2021Loss of Data; Loss of Data

  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 TWO REPORTS WERE NOT AVAILABLE FOR VIEWING. MERGE HEALTHCARE SUPPORT FOUND THAT THE REPORTS WERE NEVER CONFIRMED BUT WERE IN CONFIRMED STATUS. THE LOGS HAD BEEN TRUNCATED SO THEY WERE UNAVAILABLE FOR TROUBLESHOOTING PURPOSES. SUPPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527028 ↗
• MalfunctionSep 7, 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 MR MAX GRADIENT 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 NECESSARY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436343 ↗
• MalfunctionAug 16, 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 STROKE VOLUME (SV) LVOT DP MEASUREMENT WAS NOT MAPPED CORRECTLY. WORK BETWEEN MERGE HEALTHCARE AND THE CUSTOMER IS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN MORE INFORMATION BECOMES AVAILABLE. THIS HAS THE POTENTIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328166 ↗
• MalfunctionApr 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 (B)(6) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REQUEST RE-MAPPING OF 2 MEASUREMENTS: MITRAL REGURGITATION MEASUREMENT IS POPULATING THE MITRAL VALVE GRADIENT FIELD, AND WHEN MEASURING BOTH MITRAL REGURGITATION AND MITRAL VALVE GRADIENT, THE INCORRECT MR MEASUREMENT IS OVERWRITTEN WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749622 ↗
• MalfunctionNov 17, 2020Loss of Data; Loss of Data

  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 SUPPORT STATING THAT A RECENT REPORT WAS UNAVAILABLE IN THEIR EMR AND THAT THIS HAD RESULTED IN A DELAY OF CARE FOR A PATIENT. MERGE HEALTHCARE SUPPORT FOUND THAT THE REPORT FAILED TO EXPORT TO THE EMR BECAUSE HOSPITAL STAFF ENTERED "/WIFE" IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856392 ↗
• 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 ONE MEASUREMENT WAS INCORRECTLY MAPPED. MERGE HEALTHCARE IS CURRENTLY WORKING WITH THE CUSTOMER TO RESOLVE THIS AND AWAITING THE CUSTOMER'S RETURN FROM VACATION. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10505053 ↗
• MalfunctionAug 28, 2020Application Program Problem: Parameter Calculation Error; Patient Data Problem; Application Program Problem: Parameter Calculation Error; Patient Data 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) 2020, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT STRESS DATA WAS LABELED INCORRECTLY. MERGE HEALTHCARE SUPPORT HAS BEEN IN CONTACT WITH THE CUSTOMER MULTIPLE TIMES SINCE THIS REPORT AND IS CURRENTLY WORKING ON GATHERING FURTHER INFORMATION. AT THIS TIME, THERE ARE NO REPORTS OF

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

  MAUDE report 10468855 ↗
• MalfunctionJul 20, 2020Application Program Problem: Parameter Calculation Error; Patient Data Problem; Application Program Problem: Parameter Calculation Error; Patient Data 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 (B)(4) 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 FROM ONE PHILIPS MODALITY, THE LEFT VENTRICULAR OUTFLOW TRACK (LVOT) MEASUREMENT WAS POPULATING IN THE CLINICAL CARDIO REPORT INCORRECTLY AND THAT THE CORRECT LVOT MEASUREMENT WAS POPULATING IN THE TR (TRICUSPID REGURGITATION) VE

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

  MAUDE report 10299011 ↗
• MalfunctionFeb 7, 2020Data Problem; 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 Known Impact Or Consequence To Patient

  MAUDE report 9681178 ↗
• MalfunctionJan 24, 2020Data Problem; 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 Known Impact Or Consequence To Patient

  MAUDE report 9628032 ↗
• MalfunctionJan 3, 2020Data 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 MEASUREMENTS (MR VENA CONTRACTA AND TR VENA CONTRACTA) THAT WERE NEVER TAKEN ON THE MODALITY WERE POPULATING THE CARDIO CLINICAL REPORT. 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. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548544 ↗

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-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-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-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-1486-2017 · Apr 4, 2016 · Terminated
  Merge Cardio software.
• Z-1415-2017 · Apr 4, 2016 · Terminated
  Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
• 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-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.
• 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