Merge Unity PACS 11.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842000100331), received between Jan 1, 2019 and Oct 27, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Loss of Data” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 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 DID NOT SAVE DUE TO A WORKSTATION CRASH. A BLANK REPORT DOCUMENT WAS MANUALLY PLACED IN THE FOLDER AND THE REPORT WAS RE-DICTATED AND SUBSEQUENTLY 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10744059 ↗
• MalfunctionSep 4, 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 VIA APPLICATION LOGS THAT THE REPORT NEVER UPLOADED BECAUSE THE C DRIVE ON THE LOCAL STATION WAS FULL, WHICH PREVENTED THE REPORT FROM SAVING. SUPPORT ASSISTED THE CUSTOMER IN RE-GENERATING THE REPORT AND RECOMMENDED REVIEWING THE C DRIVE OF THE LOCAL STATION. 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 10496088 ↗
• MalfunctionMar 19, 2019Loss 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) 2019 THE CUSTOMER REPORTED AN EXAM WAS MARKED READ, HOWEVER, THERE IS NO EXAM REPORT. THE REPORT WAS SAVED, BUT NOT ASSOCIATED PROPERLY WITH THE EXAM. A CAUSE OF THE FAILED ASSOCIATION WAS NOT ABLE TO BE DETERMINED. AN INVESTIGATION SHOWED THE REPORT DID NOT UPLOAD SUCCESSFULLY AND HAD TO BE READ AGAIN BY THE DOCTOR. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT. HOWEVER, WHILE IMAGES ARE AVAILABLE, A FINALIZED REPORT NOT BEING AVAILABLE FOR SUBSEQUENT REVIEW BY THE PATIENT'S PHYSICIAN COULD POTENTIALLY RESULT IN A DELAY IN CARE THAT COULD LEAD TO HARM. REFERENCE SALES FORCE (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8431941 ↗
• MalfunctionJan 1, 2019Loss 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 DECEMBER 13, 2018 THE CUSTOMER REPORTED AN EXAM WAS COMPLETED, HOWEVER, THERE IS NO EXAM REPORT. AN INVESTIGATION SHOWED THE REPORT DID NOT UPLOAD SUCCESSFULLY AND HAD TO BE READ AGAIN BY THE DOCTOR. THE EXAM WAS READ, THERE WAS AN UPLOAD ERROR AT THE TIME OF THE SAVE EVENT. THERE WAS NO REPORTED ADVERSE EVENT TO A PATIENT. A MISSING REPORT DOES HAVE THE POTENTIAL TO DELAY PATIENT CARE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207334 ↗

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