Resubmission of initial report as per fda on 4/3/2019.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.No consequences have been reported, neither from this customer nor from the installed base.With this information, a death or serious injury is highly improbable.(b)(6).
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Due to an identified hard drive failure on the syngo.Plaza server, all studies available in short term storage (sts) were lost.As there is no archive solution in this site, is not possible to restore the data in the sts.Activities are ongoing to evaluate the exact amount of affected studies and the possibility to recover the deleted data; however, the affected data is considered as clinically relevant.The reported event occurred in (b)(6).
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