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 unconfirmed.The scanner was tested on a phantom.Image quality displayed is standard for a prevue scanner.The device was serviced, tested and returned to the customer.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 dyyiq020 showed no other similar product complaint(s) from this serial number.
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