ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5 의 리콜

Recall

RC-2018-RN-00137-1

Class II

2018-02-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00137-1

When using exactrac on a varian clinac or varian truebeam system equipped with the adi, beam requests of the treatment application have to be authorized by exactrac to enable treatment. as per the ifu, if no patient data is loaded in exactrac, exactrac always authorizes every beam request from the varian side. this is required and intended for clinical treatments where exactrac is not used for patient positioning. brainlab is clarifiying that the beam authorization by exactrac via adi is not a safety feature to ensure correct patient positioning before treatment.For any treatments performed with exactrac always verify that exactrac confirms the target position by displaying the ok icon. if a deviation of the patient position from the planned treatment position remains undetected by the user and the actual treatment beam that has been previously authorized by exactrac via adi is initialized, underdose of the planned target and/or overdose of healthy tissue could occur.

Brainlab is advising users to always follow the IFU during use and to verify that ExacTrac confirms the target position by displaying the OK icon. Brainlab is providing updated Instructions for use. For treatments that have already been performed, the actual patient position during treatment can be reviewed in the treatment report of ExacTrac, and by using the Review function in the ExacTrac software.