The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality is confirmed.The root cause of the reported problem is burrs on the lvds cutout of the front metal case.The device was serviced, tested and returned to the customer.A history review of serial number dyyk7038 showed no other similar product complaint(s) from this serial number.
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