The investigation performed found that the merge pacs software was functioning as designed.Merge pacs software does not give the customer the option to delete images from the archive, in order to prevent the loss of data.However, it appears that the customer went directly to the disks where the images were stored and deleted them.The customer does not have the images stored in another location.
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Merge pacs is a picture archiving communication system that is intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.Pacs is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities.On (b)(6) 2016 a customer reported that they were unable to retrieve some images taken in 2012 from their archive.Due to the loss of images that can be used when comparing prior studies to recent studies, there is a potential for a delay in treatment or diagnosis.The customer did not allege an injury, the need for medical intervention, or adverse consequences as a result of the unretrievable images.(b)(4).
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