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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00936-1
Product Name/Description AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery System)

AlignRT PCR Number: 249-1526

ARTG Number: 159239
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 30/09/2016
Responsible Entity alphaXRT Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.

This action has been closed out on the 22/10/2018.
Contact Information 02 9552 4090 - alphaXRT