The system was examined and the reported event was replicated an issue related to the reported event.The system was recalibrated as a preventive measure.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on march 2, 2010.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the calibration of the system.However, how or when the system became nonconforming cannot be determined conclusively.(b)(4).
|