The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of unit is displaying error code 205, even after rebooting, and screen freezes is confirmed.The root cause of the reported issue is a beamformer board failure.The device was serviced, tested and returned to the customer.
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