Merge Unity PACSRecalls & reported problems across all models
Merge Healthcare Solutions Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Merge Unity PACS by Merge Healthcare Solutions Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between May 17, 2018 and Feb 9, 2022 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Loss of Data” (38 reports).
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
Most reported Merge Unity PACS problems
Device problems
- Loss of Data38
- Computer Software Problem7
- Application Program Problem: Parameter Calculation Error1
- Defective Component1
Patient problems
- No Known Impact Or Consequence To Patient23
- No Clinical Signs, Symptoms or Conditions16
Merge Unity PACS models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Merge Unity PACS 11.1.2System, Image Processing, Radiological18 reports
- Merge Unity PACS 12.0System, Image Processing, Radiological11 reports
- Merge Unity Pacs 11.0System, Image Processing, Radiological6 reports
- Merge Unity PACS 11.2System, Image Processing, Radiological4 reports
Recent Merge Unity PACS adverse event reports
The 15 most recent reports across all models, 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 ↗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 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 ↗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 ↗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 ↗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 ↗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 ↗
Other Merge Healthcare Solutions Inc. products
All Merge Healthcare Solutions Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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