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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01290-1
Product Name/Description Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)

ARTG Number: 191025
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 3/12/2013
Responsible Entity Elekta Pty Ltd
Reason/Issue During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values. If the user does not do the quality assurance (QA) procedures after the calibration, it is possible that the user will not find the error made during the calibration

If the treatment table, gantry or collimator calibration is incorrect, and the user does not perform the recommended QA procedures, it can cause clinical mistreatment, with errors up to 6cm could go undetected and repeated over a number of fractions
Recall Action Recall for Product Correction
Recall Action Instructions As an interim measure, Elekta is recommending users perform the daily QA procedures as per the Instructions for Use (IFU) and perform a daily check to ensure the magnitude and direction of the treatment table movements are correct. If a user has X-ray Volume Imager (XVI), Elekta is recommending users perform the QA procedures as per the XVI IFU and perform the daily phantom scan.
All users of Integrity 3.1 software will be informed of a mandatory upgrade to software version 3.2 upon its release in February 2014. This action has been closed-out on 18/02/2016.
Contact Information 02 8907 1820 - Elekta