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.There is interference in the bottom of the image box.The root cause is an internal failure in the probe.No other functionality issues with the equipment were found during evaluation/servicing.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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