Retiro De Equipo (Recall) de AlignRT patient positioning/tracking video camera system Software versions up to, but not including, 5.0.1691 Affected hardware configuration: Vision RT external Gate Controller with Varian Motion Management Interface (MMI) or Siemens systems. Systems with Vision RT’s Integrated Gate Controller (IGC) are not affected.

Recall

RC-2014-RN-01220-1

Class II

2014-11-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01220-1

Contrary to the recommended start-up sequence, if the user starts the vision rt software with the gate controller key-switch in the off (‘0’) position and then turns the gate controller key-switch from the off (‘0’) to the on (‘1’) position, a message informing that the current key-switch position is ‘0’ is displayed to the user. if the user was to continue, the real time deltas displayed on the main screen of the device would correctly indicate the actual position of the patient with respect to the user-configured thresholds, but the software is not gating. if users ignore the warnings, when the patient moves out of position and the software requests a beam hold, the request is ignored by the gate controller and beam will continue to be enabled. if users fail to recognise that real time deltas are out of tolerance and the linac control console is providing visual and audible indication that the beam is on, this may lead to a geographic treatment target miss for part of the dose.

Users are advised that the device remains safe to use if the instructions detailed in the customer letter and in the Product Guide are followed. In addition, Vision RT is in the process of designing an upgrade in order to prevent this potential issue. Vision RT will contact customers by 31 March 2015 in order to update them on the status of this upgrade and to plan its installation.