Merge PACSRecalls & reported problems across all models

We found 9 models of Merge PACS by Merge Healthcare Solutions Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between May 14, 2020 and Jul 21, 2026 — classified as 1 injury, 8 malfunctions.

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

5 FDA recall records name at least one of these models by its device identifier, 3 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 PACS 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. Jul 22, 2026Open, Classified

   Software issue may cause measurements to be displayed inaccurately.

   Z-3004-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

2. Jun 30, 2026Open, Classified

   Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

   Z-2875-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

3. Jun 30, 2026Open, Classified

   Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

   Z-2874-2026 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

4. Aug 6, 2020Terminated

   Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

   Z-2944-2020 · Root cause: Software design · Recall details · FDA record ↗

5. Jul 11, 2019Terminated

   Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

   Z-2062-2019 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗

Most reported Merge PACS problems

Merge PACS models

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

• Merge PACS 9.2

  System, Image Processing, Radiological
  2 recalls1 report
• Merge PACS 8.1

  System, Image Processing, Radiological
  1 recall3 reports
• Merge PACS 8.0

  System, Image Processing, Radiological
  1 recall1 report
• Merge PACS 9.5

  System, Image Processing, Radiological
  1 recall1 report
• Merge PACS 7.3

  System, Image Processing, Radiological
  1 recall0 reports
• Merge PACS 9.4

  System, Image Processing, Radiological
  1 recall0 reports
• Merge PACS 7.2

  System, Image Processing, Radiological
  1 report
• Merge PACS 6.6.3.2

  System, Image Processing, Radiological
  1 report
• Merge PACS 8.2

  System, Image Processing, Radiological
  1 report

Recent Merge PACS adverse event reports

The 9 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894797 ↗
• InjuryMar 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERGE HEALTHCARE IS SUBMITTING THIS REPORT TO US FDA DUE TO AN ISSUE WITH A THIRD-PARTY APPLICATION USED FOR REPORTING AND DICTATION THAT LED TO A POTENTIAL PATIENT SAFETY RISK. THE THIRD-PARTY APPLICATION INTEROPERATES WITH THE COMPANY'S MERGE PACS AND MERGE WORKFLOW ORCHESTRATOR PRODUCTS. NEITHER THE THIRD-PARTY APPLICATION NOR MERGE WORKFLOW ORCHESTRATOR ARE REGULATED AS MEDICAL DEVICES. A CUSTOMER CONTACTED MERGE HEALTHCARE TECHNICAL SUPPORT ON (B)(6)2025 TO REPORT THAT A PATIENT'S IMAGING STUDY HAD BEEN READ INCORRECTLY BY A RADIOLOGIST. THE CUSTOMER ALLEGED THAT MERGE PACS AND THE DICTATION SYSTEM DISPLAYED IMAGES FOR THE INCORRECT PATIENT. AS A RESULT, A PATIENT WAS SENT OFFSITE FOR FURTHER TREATMENT. NO PATIENT HARM OCCURRED, AS HOSPITAL STAFF IDENTIFIED THAT THE CLINICAL HISTORY IN THE REPORT DID NOT MATCH THE ORDER REQUISITION FOR THE PATIENT. MERGE HEALTHCARE INITIATED AN INVESTIGATION WITH THE THIRD-PARTY VENDOR FOR THE DICTATION SYSTEM. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS DETERMINED THAT THE USER HAD OPENED TWO PATIENT EXAMS IN QUICK SUCCESSION. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE CORRECT IMAGES FOR THE PATIENT WERE DISPLAYED BY MERGE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21671425 ↗
• MalfunctionFeb 9, 2022Application Program Problem: Parameter Calculation Error; Defective Component; Application Program Problem: Parameter Calculation Error; Defective Component

  MERGE PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT IS USED FOR VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. ON (B)(6) 2022, MERGE HEALTHCARE RECEIVED AN EMAIL NOTIFICATION FROM AN APPROVED SUPPLIER, (B)(4). (B)(4) PROVIDES A 3D MEDICAL IMAGING SOFTWARE TOOLKIT THAT IS USED WITH MERGE PACS TO RENDER DICOM COMPLIANT 3D IMAGES FOR VIEWING. THE EMAIL PROVIDED INFORMATION REGARDING A REQUIREMENT THAT WAS NOT FULLY IMPLEMENTED WITHIN (B)(4) 3D MEDICAL IMAGING TOOLKIT. THE REQUIREMENT IS THAT: X AND Y PIXEL SPACING MUST BE EQUAL FOR DATA LOADED INTO 3D IMAGE RENDERING ENGINES. PER (B)(4), "ALTHOUGH CROSS SECTIONAL 3D IMAGING DATA ALMOST ALWAYS HAS EQUAL X & Y SPACING AS ADDITIONAL ASSURANCE, AND TO PROTECT FROM THE RARE EVENTS THEY ARE NOT EQUAL, OUR NEXT RELEASE OF THE SDK WILL NOW NOT ALLOW THIS DATA TO LOAD INTO 3D RENDER ENGINES (2D RENDER ENGINES WILL CONTINUE TO SUPPORT IT)." MERGE HEALTHCARE HAS RECEIVED NO COMPLAINTS FROM CUSTOMERS OR USERS OF MERGE PACS REGARDING THE RENDERING OF NON-SQUARE X,Y PIXEL 3D IMAGES. MERGE HEALTHCARE, IN CONVERSATIONS WITH (B)(6) MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502451 ↗
• MalfunctionJul 9, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STANDALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS ICONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). MERGE PACS CAN BE ACCESSED FROM WITHIN THE HOSPITAL OR ENTERPRISE, OR FROM REMOTE LOCATIONS VIA WEB-BASED ACCESS. IMAGES VIEWED ON MOBILE DEVICES MUST NOT BE USED FOR DIAGNOSTIC REVIEW. ON 6/16/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT THERE WERE DISCREPANT ROI (REGION OF INTEREST) VALUES BETWEEN 2D AND MPR IMAGES. MERGE HEALTHCARE SUPPORT WORKED WITH THE CUSTOMER TO REPRODUCE THE ISSUE. THIS ISSUE HAS BEEN CORRECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144440 ↗
• MalfunctionJun 14, 2021Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STANDALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS ICONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). MERGE PACS CAN BE ACCESSED FROM WITHIN THE HOSPITAL OR ENTERPRISE, OR FROM REMOTE LOCATIONS VIA WEB-BASED ACCESS. IMAGES VIEWED ON MOBILE DEVICES MUST NOT BE USED FOR DIAGNOSTIC REVIEW. ON (B)(6) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT THERE WERE DISCREPANT ROI (REGION OF INTEREST) VALUES BETWEEN 2D AND MPR IMAGES. MERGE HEALTHCARE SUPPORT WORKED WITH THE CUSTOMER TO REPRODUCE THE ISSUE. THE ISSUE IS CONFINED TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996143 ↗
• MalfunctionMay 25, 2021Computer Software Problem; Computer Software Problem

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STANDALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS ICONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). MERGE PACS CAN BE ACCESSED FROM WITHIN THE HOSPITAL OR ENTERPRISE, OR FROM REMOTE LOCATIONS VIA WEB-BASED ACCESS. IMAGES VIEWED ON MOBILE DEVICES MUST NOT BE USED FOR DIAGNOSTIC REVIEW. ON 4/27/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A DIFFERENT PATIENT'S PRIOR STUDY WAS SHOWING IN THE THUMBNAIL VIEW FOR A CURRENT STUDY OPEN IN THE PRIMARY VIEWER. MERGE HEALTHCARE SUPPORT WORKED WITH THE CUSTOMER TO REPRODU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881109 ↗
• MalfunctionSep 30, 2020Missing Test Results; Missing Test Results

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STANDALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS), SUCH AS ICONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). ON (B)(6) 2020, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REPORT THAT SOME IMAGES IN A MAMMOGRAPHY SERIES WERE NOT DISPLAYING AND WERE MISSED OR SKIPPED. MERGE HEALTHCARE SUPPORT IS CURRENTLY IN THE PROCESS OF ENGAGING THE CUSTOMER TO DETERMINE THE ISSUE AND NEXT STEPS. WHEN FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. BASED ON THIS, THERE IS A POTENTIAL FOR DELAY IN TREATMENT THAT COULD CAUSE HARM TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10609388 ↗
• MalfunctionAug 6, 2020Computer Software Problem; Application Program Problem: Parameter Calculation Error; Computer Software Problem; Application Program Problem: Parameter Calculation Error

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STANDALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS ICONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). ON (B)(6) 2020, MERGE HEALTHCARE RECEIVED A REPORT FROM A CUSTOMER THAT HOUNSFIELD UNIT VALUES REPORTED IN THE 3D VIEW WERE INCONSISTENT WITH THE HOUNSFIELD UNIT VALUES REPORTED IN THE 2D VIEW OF MERGE PACS. UPON INVESTIGATION, IT WAS DISCOVERED THAT PIXEL VALUE MEASUREMENTS (INCLUDING HOUNSFIELD UNIT MEASUREMENTS AND SUV MEASUREMENTS) FROM THE PROBE, ROI, AND REGION ANALYSIS AREA TOOLS ARE INCORRECT ON MULTI-PLANAR REFORMATS (MPRS)

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

  MAUDE report 10375493 ↗
• MalfunctionMay 14, 2020Computer Software Problem; Computer Software Problem

  MERGE PACS IS A STANDARDS-BASED MEDICAL IMAGING DIAGNOSTIC WORKSTATION THAT SERVES AS AN ADJUNCT TO ASSIST THE CLINICIAN TO VIEW, READ, AND REPORT THEIR FINDINGS. MERGE PACS PROCESSES AND DISPLAYS MEDICAL IMAGES FROM DICOM-COMPLIANT MODALITIES. THE DEVICE IS DESIGNED TO ENABLE EFFICIENT WORKFLOWS BY MAINTAINING CLINICIANS' WORKLISTS AND RETRIEVING AND MANAGING STUDIES FOR READING, REPORTING, COMMUNICATION, AND STORAGE. MERGE PACS SOFTWARE RUNS ON OFF-THE-SHELF COMPUTER HARDWARE AND CAN BE CONFIGURED TO OPERATE STAND ALONE OR TO INTEGRATE WITH VENDOR-NEUTRAL IMAGING ARCHIVES (VNAS) SUCH AS I CONNECT ENTERPRISE ARCHIVE (ICEA) FOR IMAGE STORAGE, AND WITH RADIOLOGICAL AND HOSPITAL INFORMATION SYSTEMS (RIS AND HIS) AND MEDICAL RECORD SYSTEMS (EMR, EHR, ETC.). ON (B)(6) 2020, THE CUSTOMER REPORTED THAT A STUDY CAME IN AND THE CT TECH MANUALLY CHANGED FROM UNVERIFIED TO UNREAD AND SET THE CUSTOM STATUS TO ER. IT UPDATED EVERYTHING AS EXPECTED AND SHOWED ON THE RADIOLOGST'S ER WORKLIST. A LITTLE LATER, THE CT TECH SENT IN SCANNED PAPERWORK, WHICH REVERTED THE STATUS BACK TO UNVERIFIED, THEREBY, REMOVING THE STUDY FROM THE RADIOLOGIST'S ER WORKLIST (WHICH IS EXPECTED BEHAVIOR). HOWEVER, THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10057595 ↗

Other Merge Healthcare Solutions Inc. products

• Merge Cardio6 models · 34 reports · 5 recalls
• Merge Hemo5 models · 33 reports · 1 recall
• Merge OrthoPACS2 models · 0 reports · 1 recall
• Merge Unity PACS4 models · 39 reports