The device has not been received by the manufacturer, at this time, for evaluation.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 artifacts in the probe image is confirmed.The probe displays 'artifacts' on the ultrasound image.The root cause of the reported issue is an internal probe failure.No other functionality issues with the equipment were found during evaluation/servicing.The device was discarded due to being irreparable.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
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