The investigation was completed by conducting a thorough evaluation of the product and the reported information.A highly unlikely chain of events has been identified in which the internal source cable guide displacement can cause incorrect source cable positioning.For this to occur, all of the following conditions need to be met simultaneously: both internal guiding tubes for the check cable and source cable are defective.The obstruction in the cable path is not detected by the check cable.The obstruction in the cable path occurs after all channels passed the check cable checks.In addition, it is improbable that this error condition would not have been noticed during the mandatory safety, performance and functional tests that are performed during each source exchange or planned maintenance: · the cable obstructions detection circuits tests.· transfer tube connection test.· cable alignment verification done after these tests.This issue could cause treatment interruption or in a very unlikely chain of event, incorrect source positioning.An ifsn and ifsm will be released and contains instructions on how to inspect the flexitron internal cable guides.
|