Merge Unity PACS 11.1.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00842000100058), received between May 17, 2018 and Nov 24, 2020 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Loss of Data” (18 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 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 11/05/2020, A CUSTOMER CONTACTED MERGE HEALTHCARE TO INFORM US THAT THEY WERE UNABLE TO VIEW AN EXAM REPORT FROM A RECENT EXAM. 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 10896943 ↗
• MalfunctionNov 18, 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. MERGE HEALTHCARE DETERMINED UPON INVESTIGATION THAT THE REPORT SAVED BUT FAILED TO UPLOAD. LOGS WERE REVIEWED AND DID NOT INDICATE ANY ISSUE. A BLANK REPORT DOCUMENT WAS MANUALLY PLACED IN THE FOLDER 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 10863174 ↗
• MalfunctionAug 11, 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 10393576 ↗
• MalfunctionAug 20, 2019Computer 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. THE CUSTOMER CONTACT REPORTED ON (B)(6) 2019 THERE WERE FIVE EXAMS WITH CORRUPTED REPORTS FROM (B)(6) 2019 FROM TWO DIFFERENT READING STATIONS. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT. HOWEVER, WHILE IMAGES WERE AVAILABLE, A CORRUPTED REPORT COULD POTENTIALLY RESULT IN A DELAY IN CARE THAT COULD LEAD TO HARM. REFERENCE COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8911821 ↗
• MalfunctionMay 2, 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 COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573112 ↗
• MalfunctionApr 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 COMPLAINT NUMBER: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531352 ↗
• MalfunctionApr 15, 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: COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514952 ↗
• 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 REPORT WAS UNABLE TO OPEN. 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 (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8432143 ↗
• 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 COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8432018 ↗
• MalfunctionFeb 18, 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 BECAUSE THE READING STATION LOGS WERE TRUNCATED. 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 COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348302 ↗
• MalfunctionFeb 13, 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 OR SAVE EVENT IN THE AUDIT TRAIL. 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 COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338082 ↗
• 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 (B)(6) 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. 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. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207333 ↗
• MalfunctionDec 28, 2018Loss 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) 2018 A CUSTOMER REPORTED AN EXAM REPORT FAILED TO UPLOAD. THE MERGE HEALTHCARE, UNITY TECHNICIAN'S INVESTIGATION SHOWED THAT A SAVE EVENT DID OCCUR IN THE AUDIT TRAIL. HOWEVER, THE READ REPORT ITSELF FAILED TO UPLOAD PROPERLY. 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. HOWEVER, THE CUSTOMER DID NOT ALLEGE ANY HARM, SERIOUS INJURY OR DEATH AS A RESULT OF THIS ISSUE. REFERENCE (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202528 ↗
• MalfunctionDec 14, 2018Loss 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) 2018 THE CUSTOMER REPORTED AN EXAM REPORT IS CORRUPT. THE MERGE HEALTHCARE UNITY TECH'S INVESTIGATION SHOWED THAT THE REPORT DID SAVE SUCCESSFULLY, HOWEVER, THE MS WORD DOCUMENT (EXAM REPORT) WAS CORRUPT. 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. HOWEVER, THE CUSTOMER DID NOT ALLEGE ANY HARM, SERIOUS INJURY OR DEATH AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT NUMBER (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166450 ↗
• MalfunctionDec 3, 2018Loss 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) 2018 THE CUSTOMER REPORTED THERE WERE NO REPORTS FOR 6 MAMMOGRAPHY EXAMS. THE REPORTS WERE READ BY ONE PHYSICIAN ON A HOME READING STATION IN ONE SESSION. THE MERGE HEALTHCARE UNITY SUPPORT TECHNICIAN INVESTIGATED THE EXAMS, AND ALL OF THEM DID HAVE REPORT IDS WITH FOLDERS IN I:\REPORTS. TWO OF THE SIX EXAM REPORTS WERE RECOVERED, THE OTHER 4 EXAMS WERE RE-READ BY THE PHYSICIAN. 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. HOWEVER, THE CUSTOMER DID NOT ALLEGE ANY HARM, SERIOUS INJURY OR DEATH AS A RESULT OF THIS ISSUE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124285 ↗
• MalfunctionOct 18, 2018Loss 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) 2018 THE CUSTOMER REPORTED THAT AN EXAM WAS COMPLETED, HOWEVER, THERE IS NO EXAM REPORT. THE UNITY TECHNICIAN'S INVESTIGATION SHOWED THE REPORT DID NOT UPLOAD SUCCESSFULLY. THE EXAM WAS READ, THERE WAS AN UPLOAD ERROR--THE LOCALLY CACHED REPORT WAS CORRUPT OR MISSING WHEN UNIVERSAL MANAGER TRIED TO UPLOAD IT: THE EXAM WAS RE-READ BY THE PHYSICIAN. 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. HOWEVER, THE CUSTOMER DID NOT ALLEGE ANY HARM, SERIOUS INJURY OR DEATH AS A RESULT OF THIS ISSUE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7981783 ↗
• MalfunctionJul 27, 2018Loss 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) 2018 THE CUSTOMER REPORTED AN EXAM WAS COMPLETED BUT THERE IS NO EXAM REPORT. UNITY SUPPORT INVESTIGATION SHOWED THE REPORT DID NOT UPLOAD SUCCESSFULLY, AND WILL HAVE TO BE RECREATED. THE AUDIT TRAIL DOES SHOW A "REPORT SAVE" EVENT. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT. A MISSING REPORT DOES HAVE THE POTENTIAL TO DELAY PATIENT CARE. REFERENCE SALES FORCE COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728559 ↗
• MalfunctionMay 17, 2018Loss 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) 2018 A CUSTOMER REPORTED TO MERGE UNITY TECHNICAL SUPPORT THAN AN EXAM REPORT WAS MISSING. THE MERGE UNITY SUPPORT TECHNOLOGIST'S INVESTIGATION INTO THE CUSTOMER'S ALLEGATION SHOWED THAT THE REPORT DID NOT UPLOAD SUCCESSFULLY, AND WOULD HAVE TO BE RECREATED. THE AUDIT TRAIL DOES SHOW A "REPORT SAVE" EVENT. 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. HOWEVER, THE CUSTOMER DID NOT ALLEGE ANY HARM, SERIOUS INJURY OR DEATH AS A RESULT OF THIS ISSUE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7524223 ↗

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