H10 h3, h6: the device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A complaint history review found similar reports.There was no lot number, or part number noted in the initial investigation documents so we are unable to conduct a dhr review as a part of the investigation.It was not confirmed if the product met manufacturing specifications.A relationship, if any, between the subject device and the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.A factor that could have contributed to the reported issue is if there was an issue with the illuminator leds on the camera.They can go bad over time and cause floating "dead zones" in the camera view.
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