Resubmission of initial report as per fda on 4/3/2019 per the potential complaint report, there was no injury associated with this issue.No data mixup or loss occurred which would result in the need for a patient rescan.Customer changed the archive settings in source manager due to which studies have been getting deleted from cache.Customer understands data loss was due to this misconfiguration.This issue has been addressed at the site, therefore no new data loss has occurred.The risk to the customer / patients at the site from the product is evaluated as none.The product documentation did not contribute to the misconfiguration.The risk to the customer / patients from the data loss is evaluated as low as the clinical study reports for the lost images are still available.The syngo dynamics system did not cause or contribute to the loss of data.The system is working as specified.
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