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.On (b)(6) 2016, a customer alleged that structured reports were displaying measurement units in cm versus mm as sent from the modality.Due to the alleged length unit measurement issue, this issue is being reported as there is a potential for a misdiagnosis or mistreatment of a patient.The customer has not reported any known impacts to a patient.(b)(4).
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A case was opened with the development group regarding this issue.It was discovered that a token to convert centimeters to millimeters was placed in the incorrect position in the configuration file.Unity tech changed the location of the token and confirmed with customer the issue was resolved.This was determined to be a one off issue as the instructional text does show the token in the networked reporting section.The user confirms the issue is resolved and they have once again turned on the structured report and are receiving the information as desired in mm rather than cm.The measurements were always correct, however, in pre-natal imaging the measurement must be in mm and the system was displaying in cm.This issue is resolved and no further investigation/action will be taken.Revised information contained in this supplemental report includes the following: h6 - evaluation codes: methods code: 22 software evaluaiton(blank in initial report).Results code: 104 software problem.Conclusions code: 17 evaluation conclusion.H10 - indication of additional manufacturer information is contained in this follow-up report.
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