The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.There was equipment which was replaced as a preventive measure and was unrelated to the reported event.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 april 30, 2012.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.(b)(4).
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