The system was examined and the reported event was not replicated.However, as a preventive measure the footswitch cable (which belongs to the system) was replaced.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 february 13, 2008.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 established.(b)(4).
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