Merge Unity PACS 12.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842000100744), received between Jul 3, 2020 and Feb 9, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Loss of Data” (10 reports).

6 other recalls cover devices cleared under the same FDA submission (K041935); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022Application Program Problem: Parameter Calculation Error; Defective Component; Application Program Problem: Parameter Calculation Error; Defective Component

  MERGE UNITY PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT ALLOWS VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. MERGE UNITY PACS INTERFACES TO VARIOUS STORAGE AND PRINTING DEVICES USING DICOM OR SIMILAR INTERFACE STANDARDS. MERGE UNITY PACS DISPLAYS, STORES, PRINTS, AND TELECOMMUNICATES IMAGES FROM A NUMBER OF MEDICAL MODALITIES, INCLUDING BUT NOT LIMITED TO MRI, CT, US, PET, DXA (BONE DENSITOMETRY), NUCLEAR IMAGING, COMPUTED RADIOGRAPHY, DIGITAL RADIOGRAPHY, DIGITIZED FILMS, DIGITAL PHOTOGRAPHS AND MAMMOGRAPHIC IMAGES. ON 1/11/2022, MERGE HEALTHCARE RECEIVED AN EMAIL NOTIFICATION FROM AN APPROVED SUPPLIER, FOVIA MEDICAL INC. FOVIA PROVIDES A 3D MEDICAL IMAGING SOFTWARE TOOLKIT THAT IS USED WITH MERGE UNITY PACS TO RENDER DICOM COMPLIANT 3D IMAGES FOR VIEWING. THE EMAIL PROVIDED INFORMATION REGARDING A REQUIREMENT THAT WAS NOT FULLY IMPLEMENTED WITHIN FOVIA'S 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 FOVIA, "ALTHOUGH CROSS SECTIONAL 3D IMAGING DATA ALMOST ALWAYS HAS E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502481 ↗
• MalfunctionSep 10, 2021Loss of Data; Loss of Data

  MERGE UNITY 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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS INACCESSIBLE. MERGE HEALTHCARE TECHNICAL SUPPORT DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT WAS PUT IN PLACE BY MERGE HEALTHCARE TECHNICAL SUPPORT AND THE REPORT WAS SUBSEQUENTLY VIEWABLE AS EXPECTED. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457090 ↗
• MalfunctionSep 10, 2021Loss of Data; Loss of Data

  MERGE UNITY 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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS INACCESSIBLE. MERGE HEALTHCARE TECHNICAL SUPPORT DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT WAS PUT IN PLACE BY MERGE HEALTHCARE TECHNICAL SUPPORT AND THE REPORT WAS SUBSEQUENTLY VIEWABLE AS EXPECTED. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456978 ↗
• MalfunctionAug 20, 2021Loss of Data; Loss of Data

  MERGE UNITY 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 8/3/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS INACCESSIBLE. MERGE HEALTHCARE DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT DOCUMENT WAS MANUALLY PLACED IN THE FOLDER AND THE REPORT WAS RE-DICTATED AND SUBSEQUENTLY VIEWABLE AS EXPECTED. THIS SITE HAS REGULAR AND PERSISTENT NETWORK ISSUES THAT AFFECT REPORT UPLOADS. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350982 ↗
• MalfunctionAug 18, 2021Loss of Data; Loss of Data

  MERGE UNITY 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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS INACCESSIBLE. MERGE HEALTHCARE TECHNICAL SUPPORT DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT WAS PUT IN PLACE BY MERGE HEALTHCARE TECHNICAL SUPPORT AND THE REPORT WAS SUBSEQUENTLY VIEWABLE AS EXPECTED. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336867 ↗
• MalfunctionAug 17, 2021Loss of Data; Loss of Data

  MERGE UNITY 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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS INACCESSIBLE. MERGE HEALTHCARE TECHNICAL SUPPORT DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT WAS PUT IN PLACE BY MERGE HEALTHCARE TECHNICAL SUPPORT AND THE REPORT WAS SUBSEQUENTLY VIEWABLE AS EXPECTED. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333495 ↗
• MalfunctionJul 28, 2021Loss of Data; Loss of Data

  MERGE UNITY 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 7/4/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS MISSING. MERGE HEALTHCARE TECHNICAL SUPPORT DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. MERGE HEALTHCARE TECHNICAL SUPPORT CONFIRMED ON 7/22/2021 THAT THE CUSTOMER DICTATED A NEW REPORT AND THAT REPORT WAS SUBSEQUENTLY VIEWABLE AS EXPECTED. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242156 ↗
• MalfunctionJun 14, 2021Loss of Data; Loss of Data

  MERGE UNITY 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 5/19/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS MISSING. MERGE HEALTHCARE DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT DOCUMENT WAS MANUALLY PLACED IN THE FOLDER ON (B)(6) 2021 AND THE REPORT WAS RE-DICTATED AND SUBSEQUENTLY VIEWABLE AS EXPECTED. THIS SITE HAS REGULAR AND PERSISTENT NETWORK ISSUES THAT AFFECT REPORT UPLOADS. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995495 ↗
• MalfunctionJun 2, 2021Loss of Data; Loss of Data

  MERGE UNITY 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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS MISSING. MERGE HEALTHCARE DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT DOCUMENT WAS MANUALLY PLACED IN THE FOLDER ON (B)(6) 2021 AND THE REPORT WAS RE-DICTATED AND SUBSEQUENTLY VIEWABLE AS EXPECTED. THIS SITE HAS REGULAR AND PERSISTENT NETWORK ISSUES THAT AFFECT REPORT UPLOADS. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925437 ↗
• MalfunctionJun 2, 2021Loss of Data; Loss of Data

  MERGE UNITY 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) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT A PATIENT REPORT WAS MISSING. MERGE HEALTHCARE DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. A BLANK REPORT DOCUMENT WAS MANUALLY PLACED IN THE FOLDER ON (B)(6) 2021 AND THE REPORT WAS RE-DICTATED AND SUBSEQUENTLY VIEWABLE AS EXPECTED. THIS SITE HAS REGULAR AND PERSISTENT NETWORK ISSUES THAT AFFECT REPORT UPLOADS. NO FURTHER ACTION IS NECESSARY AT THIS TIME. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT CN-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925232 ↗
• MalfunctionJul 3, 2020Computer Software Problem; Loss of Data; Computer Software Problem; Loss of Data

  MERGE UNITY 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) 2020, THE CUSTOMER REPORTED RECEIVING AN EXAM REPORT WITH NO REPORT BODY TO (B)(6) HEALTH IMAGING ON THE SAME DAY. TROUBLESHOOTING FROM (B)(6) HEALTH IMAGING SUPPORT FOUND THAT THERE WERE NO PATIENT DEMOGRAPHICS, BODY, OR CONCLUSION DATA INCLUDED IN THE REPORT FILE. THERE WAS A REPORT SAVE EVENT IN THE AUDIT TRAIL. USING THE REVISION BUTTON FROM THE DICTATION DIALOG BOX, THE REPORT TEMPLATE WAS RE-GENERATED AND THE REPORT WAS THEN VIEWABLE AS EXPECTED. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10227697 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041935. One submission often covers many models, so check the product and lot details in each record.

• Z-3105-2017 · Aug 14, 2017 · Terminated
  Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and informatio
• Z-2566-2018 · Aug 7, 2017 · Terminated
  Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and informati
• Z-1426-2017 · Apr 8, 2016 · Terminated
  DR Systems Unity PACS software, now known as Merge Unity PACS
• Z-1385-2017 · Apr 8, 2016 · Terminated
  DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection,
• Z-0939-2017 · Oct 15, 2015 · Terminated
  DR Systems Unity PACS software, now known as Merge Unity PACS software.
• Z-2551-2016 · Jul 23, 2015 · Terminated
  Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, te