The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.Device not returned, at this time.
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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 poor image quality was unconfirmed.The scanner was evaluated and any noise in the image was found to be within the acceptable range for a sr 8 scanner with detachable probe.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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