G4: 09jan2020.B4: (b)(6) 2020.The remote support engineer confirmed the reported issue.The remote support engineer stated the unit will not be repaired and will be removed from service.Part was not returned to failure investigation (fi).The root cause cannot be determined until the device is returned and investigated.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|