Merge Cardio 10.3Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00842000100041), received between Aug 12, 2018 and Dec 23, 2020 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Data Problem” (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, 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-1399-2025 · 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 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 VALVE PEAK E VELOCITY WAS DISPLAYING INCORRECTLY ON THE CARDIO CLINICAL REPORT. UPON FURTHER INVESTIGATION, MEASUREMENT MAPPING STRINGS WERE ANALYZED BY MERGE HEALTHCARE SUPPORT AND IT WAS DETERMINED THAT THE E/E' AVERA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066481 ↗
• MalfunctionOct 28, 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 10/6//2020, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT A RECENT REPORT WAS NOT AVAILABLE FOR VIEWING. MERGE HEALTHCARE SUPPORT FOUND THAT THE REPORT WAS NEVER CONFIRMED BUT WAS IN CONFIRMED STATUS. THE LOGS HAD BEEN TRUNCATED SO THEY WERE UNAVAILABLE FOR TROUBLESHOOTING PURPOSES. SUPPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10749232 ↗
• MalfunctionOct 22, 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 THREE MEASUREMENTS WERE MAPPED INCORRECTLY (MEAN VELOCITY RATIO, AORTIC VALVE AREA MEAN VELOCITY, AND AORTIC VALVE AREA BSA MEAN VELOCITY). MERGE HEALTHCARE IS CURRENTLY WORKING WITH THE CUSTOMER TO RESOLVE THIS ISSUE WITH TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10721794 ↗
• MalfunctionSep 24, 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 TO REPORT THAT A RECENT REPORT WAS NOT AVAILABLE FOR VIEWING. MERGE HEALTHCARE SUPPORT FOUND THAT THE REPORT WAS NEVER CONFIRMED BUT WAS 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 10582020 ↗
• MalfunctionJul 17, 2020Patient Data Problem; 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 STATING THAT IVC (INFERIOR VENA CAVA) MEASUREMENTS WERE MISSING IN CLINICAL REPORTING AND THAT THE IVC MEASUREMENT WAS POPULATING THE IVS (INTRAVENTRICULAR SEPTUM) FIELD ON THE CLINICAL CARDIO REPORT. DUE TO INCORRECT VALUES DISPLAYING ON THE CL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10291861 ↗
• MalfunctionApr 13, 2020Application Program Problem: Parameter Calculation Error; Data Problem; Application Program Problem: Parameter Calculation Error; 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, DURING INTERNAL TESTING OF A NEW RELEASE BY MERGE HEALTHCARE, IT WAS FOUND THAT THE LENGTH MEASUREMENTS IMPORT TO THE DEPTH LOCATION IN THE VEIN MEASUREMENT TABLE FOR THE VEIN ANATOMY OF THE LEG. THIS OCCURS IN THE 5.0 VERSION OF VASCULAR REPORTING WHICH IS CURRENTLY IN CARDIO VERSIO

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

  MAUDE report 9952834 ↗
• MalfunctionApr 3, 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 (B)(4). MERGE CARDIO IS IMAGE DATA STORAGE AND DISPLAY SOFTWARE THAT ACCEPTS DICOM (DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE) IMAGE DATA FIL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9925049 ↗
• MalfunctionMar 4, 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 9786047 ↗
• MalfunctionApr 1, 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 CALLED MERGE CARDIO SUPPORT STATING THERE WAS A REPORT WAS IN CONFIRMED STATUS WHEN IT WAS ACTUALLY ONLY QC STATUS. QC REPORTS WITH THE STATUS OF CONFIRMED COULD LEAD TO DELAY OF TREATMENT AS THE REPORT HAS NOT ACTUALLY BEEN READ BY A PHYSICIAN. THE INCORRECT STATUS OF THE REPORT MAY NOT BE READILY APPARENT TO A USER. THERE HAS BEEN NO ALLEGATION OF AN INJURY OR IMPACT TO A PATIENT AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8470571 ↗
• MalfunctionNov 27, 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)(6) 2018, THE CUSTOMER ALLEGED THE REPORT WAS NOT GOING TO THEIR EMR. UPON INVESTIGATION, IT WAS FOUND THAT THE REASON THE REPORT NEVER EXPORTED TO THE CUSTOMER'S EMR, EPIC. THIS WAS DUE TO IT BEING INCORRECTLY IN CONFIRMED STATUS INSTEAD OF BEING IN QC STATUS AND ACTUALLY CONFIRMED. MERGE CARDIO SUPPORT CORRECTED THE ISSUE BY CHANGING THE STATUS IN THE DATABASE QC REPORTS WITH THE STATUS OF CONFIRMED COULD LEAD TO DELAY OF TREATMENT AS IT HAS NOT ACTUALLY BEEN READ BY A PHYSICIAN AND AS A RESULT MAY NOT BE READILY APPARENT TO A CLINICIAN. HOWEVER, THERE HAVE BEEN NO ALLEGATIONS OF HARM AS A RESULT OF THIS ISSUE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109331 ↗
• MalfunctionOct 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)(6) 2018, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT WRONG RA VOLUME WAS BROUGHT FORWARD. 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. HOWEVER, THERE HAVE BEEN NO REPORTS OF HARM OR INJURY AS A RESULT OF THIS ISSUE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8017660 ↗
• MalfunctionAug 15, 2018Computer Software Problem; Patient Data Problem; Computer Software Problem; Patient 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. THE MERGE CARDIO AND TOMTEC INTEGRATION ALLOWS USERS TO VIEW MEDICAL IMAGES IN THE TOMTEC CLIENT (IMAGECOM) ON A MERGE CARDIO WORKSTATION WITHOUT HAVING TO MANUALLY ENTER PATIENT OR STUDY INFORMATION INTO THE TOMTEC APPLICATION. IMAGECOM IS A CLINICAL APPLICATION PACKAGE FOR HIGH PERFORMANCE PC PLATFORMS BASED ON MICROSOFT WINDOWS OPERATING SYSTEM STANDARDS. IMAGECOM IS SOFTWARE FOR THE RETRIEVING, REVIEWING, MEASURING, AND REPORTING OF DICOM DATA, FOR THE US. IN THIS INTEGRATION, THE MODALITY SENDS ALL STUDIES CONTAINING A VALID ACCESSION NUMBER TO THE ENTERPRISE ARCHIVE (EA). IMAGECOM IS INVOKED FROM THE MERGE CARDIO WORKSTATION. THE MODALITY SENDS ALL STUDIES TO THE ENTERPRISE ARCHIVE. SECONDARY CAPTURE (SC) OR STRUCTURED REPORT (SR) IMAGES ARE SENT BACK AN INTEGRATION APPLICATION, I.E. TOMTEC, FROM TO THE EA. SC IMAGES CAN BE VIEWED IN MERGE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7787850 ↗
• MalfunctionAug 12, 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)(6) 2018, A CUSTOMER CONTACTED MERGE HEALTHCARE AND STATED THAT DIAGNOSTIC MEASUREMENTS TAKEN BY THEIR MODALITY NEEDED TO BE CORRECTED. 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. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7775806 ↗

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-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-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-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-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-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-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