Merge pacs (picture archiving communication system) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.On (b)(6) 2013 a customer reported that a study status has been changed incorrectly.The logs reported that the study was changed by a staff member; however the staff member did not have system permissions to do so.Merge healthcare identified the root cause to be a design flaw where any user with the change workflow status button can pde any study, even if the user does not have permissions to use the pde tool.There was no report of patient injury.(b)(4).
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