The investigation of the reported issue was completed by our experts with the following results.The root cause of the deviation was identified as a defective small focus of the x-ray tube.Following the replacement of the defective x-ray tube, the constancy test was passed.The x-ray tube is equipped with a large and a small focus.To be able to continue with radiation exposure and patient treatment in the event of a defect focus, the system switches to a functioning focus.However, the replacement focus has different performance data, which then affects the selection of other exposure parameters (tube voltage, tube current, exposure time, copper filter) in the constancy test.As a result, the constancy test is not passed.During normal system use while performing a procedure, such an error is displayed to the user with the error message "small focus defect, sc".The instructions for use contain adequate instructions for this scenario.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.
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