The device has not been received by the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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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 the screen is non responding properly is confirmed.The root cause of the reported failure of the scanner boots to a half screen due to an internal failure of the lcd.The device was serviced, tested and returned to the customer.A history review of serial (b)(6) showed no other similar product complaint(s) from this serial number.
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