Merge Unity Pacs 11.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842000100461), received between Jun 24, 2020 and Aug 17, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Loss of Data” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 7/23/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE SUPPORT TO REPORT THAT TWO PATIENT REPORTS WERE INACCESSIBLE. MERGE HEALTHCARE TECHNICAL SUPPORT DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE NOT AVAILABLE FOR REVIEW. BLANK REPORTS WERE PUT IN PLACE BY MERGE HEALTHCARE TECHNICAL SUPPORT AND THE REPORTS WERE 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 12331605 ↗
• 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 (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. 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 12241778 ↗
• MalfunctionSep 8, 2020Loss 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) 2020, A CUSTOMER CONTACTED MERGE HEALTHCARE TO INFORM US THAT THEY WERE UNABLE TO VIEW AN EXAM REPORT FROM A RECENT EXAM. UPON INVESTIGATION AND TROUBLESHOOTING BY MERGE HEALTHCARE SUPPORT, IT WAS DETERMINED THAT THE REPORT NEVER UPLOADED. ONCE A BLANK WORD DOC WAS CREATED AND THE REPORT TEMPLATE WAS REGENERATED, THE CUSTOMER WAS ABLE TO READ THE REPORT SUCCESSFULLY. 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 10502734 ↗
• MalfunctionAug 15, 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, A CUSTOMER CONTACTED MERGE HEALTHCARE TO INFORM US THAT THEY WERE UNABLE TO VIEW AN EXAM REPORT FROM A RECENT EXAM. UPON INVESTIGATION AND TROUBLESHOOTING BY MERGE HEALTHCARE SUPPORT, IT WAS DETERMINED THAT THE REPORT NEVER UPLOADED. ONCE A BLANK WORD DOC WAS CREATED, AND THE REPORT TEMPLATE WAS REGENERATED, THE CUSTOMER WAS ABLE TO READ THE REPORT SUCCESSFULLY. 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. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411790 ↗
• MalfunctionAug 15, 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, A CUSTOMER CONTACTED MERGE HEALTHCARE TO INFORM US THAT AN EXAM REPORT WAS MISSING FROM A RECENT EXAM. CLICKING ON THE REPORT BUTTON RESULTS IN AN ERROR STATING "THE REPORT IS NOT FOUND". ATTEMPTING TO OPEN THE REPORT WITH TRANSCRIPTION RESULTS IN AN ERROR STATING "OBJECT NOT FOUND." UPON INVESTIGATION AND TROUBLESHOOTING BY MERGE HEALTHCARE SUPPORT, IT WAS DETERMINED THAT HE REPORT WAS SAVED, BUT INVESTIGATING THE CONTAINING FOLDER INDICATED THAT NO DATA WAS UPLOADED AT THE TIME. THERE WAS A REPORT SAVE EVENT IN 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 10411776 ↗
• MalfunctionJun 24, 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 A "NO OBJECT FOUND" ERROR WHEN TRYING TO OPEN A REPORT FOR DICTATION TO IBM WATSON HEALTH IMAGING ON (B)(6) 2020. TROUBLESHOOTING FROM IBM WATSON HEALTH IMAGING SUPPORT FOUND THAT THE REPORT FOLDER WAS EMPTY, CAUSING THE "NO OBJECT FOUND" ERROR, AND THAT THERE WAS A REPORT SAVE EVENT PRESENT IN THE DEVICE AUDIT TRAIL. IBM WATSON HEALTH IMAGING SUPPORT REGENERATED THE REPORT TEMPLATE AND SAVED IT IN DICTATED (DID) STATUS. THE REPORT WAS SAVED WITH THE NEW TEMPLATE. THE REPORT WAS THEN READABLE. 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 10192498 ↗

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-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-1426-2017 · Apr 8, 2016 · Terminated
  DR Systems Unity PACS software, now known as Merge Unity PACS
• 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