Retiro De Equipo (Recall) de AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery System)

Recall

RC-2016-RN-00936-1

Class I

2016-09-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00936-1

Vision rt has been notified that unintended changes can be made to the planned couch rotation parameter during patient set-up. this can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with the alignrt device prior to treatment with truebeam radiotherapy delivery system.When a request to update the couch position is sent to the truebeam via the alignrt device using the move couch function, the request may not be processed as expected. if the couch rotation in the alignrt device does not match the planned couch rotation of the field selected on the truebeam, this can result in a significant change to the planned couch rotation value. when the planned value is changed, the original plan value is overwritten at the console. this will result in the treatment plan couch value being updated unintentionally and a treatment misadministration may occur. there have been no reports of patient harm due to this issue.

Vision RT is advising users to not use the “Move Couch” function if the couch rotation value set in the AlignRT device does not match the planned couch rotation for the treatment field. Vision RT is investigating a solution for this issue.