There was one malfunction event reported with the scan body component having a connection issue.Product was returned for investigation.Because a valid and confirmed lot number was provided a review of the production records took place.The review did not note any non-conformances.So, the conclusion was determined to have been manufactured to specification.A review of the returned product did not no significant deformation or damage was observed around the scan body.The product passed an ivt test.Hence, concluding the product functioned as designed.The reported issue could not be replicated.(b)(4).
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