Events

Recall of Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Elekta Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01290-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01290-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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 calibrationif 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.
  • Action
    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.

Device

Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)
  • Model / Serial
    Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)ARTG Number: 191025
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DHTGA