(b)(4).Legal manufacturer: hcs (b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The unit was calibrated to resolve the reported issue.Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program.As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr.According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification.Therefore, this event is being reported as an individual mdr report due 10/16/2019.
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