Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00636-1
Product Name/Description Hexapod iGUIDE 2.1, iGUIDE 2.2

ARTG Number: 187340
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 19/05/2016
Responsible Entity Elekta Pty Ltd
Reason/Issue The manufacturer has identified a software issue which may lead to incorrect patient positioning during treatment. In a specific scenario the software may prompt the user several times to move the HexaPOD to its DRIVE (*START) position.

If the user follows this request the HexaPOD will move to DRIVE (*START). In a consecutive step iGUIDE shows hints to move the couch top with the Precise Table back to the initial imaging position. However, this position is reached only with a coarse movement. The final fine adjustment move, executed by the HexaPOD, is missing.

The coarsely reached imaging position becomes the new registered position for the actual Position Error Correction (PEC) movement to the target position. A theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement.
Recall Action Recall for Product Correction
Recall Action Instructions Electa advises users to avoid imaging in the PARK (*LOAD) position. If the user has performed imaging when the HexaPOD is not in the DRIVE (START*) position, cancel all move to DRIVE (START*) requests. Thus the HexaPOD remains in the imaging position. If the user then applies the PEC the HexaPOD will reach the target in the specified accuracy. The movement to the target will be a combination of Precise Table and HexaPOD moves. In case of any doubts perform a verification scan.
A software update which will correct the behaviour of the affected iGUIDE versions 2.1 and 2.2 will be provided to the affected customers free of charge as soon as it becomes available.

This action has been closed out on 19/10/2018
Contact Information 02 8907 1800 - Elekta