U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Accelerator, linear, medical - Product Code IYE
원인
If by mistake the initial pre-treatment imaging was performed before the hexapod was moved to the drive (*start) position, iguide offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
조치
Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation.
Corrective Action #2: Permanent Solution Software Upgrade
A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017.
Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.