Resubmission of initial report as per fda on 4/3/2019.Activities are ongoing to evaluate the exact amount of affected data; however, the affected data is considered as clinically relevant.The product syngo.Plaza did not contribute to the data loss, as the issue is related to a hardware failure and the syngo.Plaza is a software solution only (b)(6).
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Per the potential complaint report, there was no injury associated with this issue.Due to an identified hardware failure in network attached storage (nas), there are missing folders containing patient images in the configured nas (nas1).A backup nas is configured, however, it is managed by a 3rd party application and not configured in the syngo.Plaza system.Contents of nas1 and nas2 are identical.Both nas systems have a large amount of empty folders for dates ranging between january 6, 2017 and april 19, 2017.The reported issue occurred in (b)(6).
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