H10 h3, h6: the device was used in treatment when the navio software unexpectedly exited out of the case.Case log files were returned for evaluation.Dhr review found that the software version (navio rc-5205) has been validated.A complaint history review identified similar events.We could confirm there was a relationship established between the reported event and the device.Review of the log files confirmed the exit occurred while in the planning phase of a ukr procedure.The malfunction was due to a software failure and this issue is being investigated by the software engineering team.
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