The device referenced in this report was not returned to siemens for evaluation; however, the system log files were captured and reviewed.During the review, it was found that the software was not storing images due to "check-in" failures.When submitting patient information identical to an existing patient, except for case differences in the patient name, a software bug will not allow storing of images.The image storing issue was resolved in software updates va35e (16 dec 2015), vb10d (03 jun 2016), and vb20a (17 apr 2017).(b)(4).
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While preparing for an internal audit, complaints that were evaluated as part of a health risk evaluation were reviewed for alignment to the corrective actions that were taken.The complaints were filed per 21 cfr 803.In reviewing these complaints it was discovered that other complaints were missed in regards to mdr reporting.These complaints are now being submitted as mdrs.There was a fsca for all sc2000 customers in 2015 (fda # z-2783-2015).It was reported that the ultrasound system would not acquire a clip while using the 4z1 transducer.After the user replaced the transducer with a 4c1, images were able to be acquired.There was no patient adverse event reported.No additional information was provided.
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