Events

Recall of Integrity R1.1, R3.0 and R3.1(digital 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-2014-RN-00010-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00010-1
  • 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 the incorrect values or invert a value. 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. this could result in delivering the treatment with the patient in the incorrect position resulting in clinical mistreatment.
  • Action
    Users are asked to undertake QA procedures in accordance with the instructions for use (IFU) for Integrity, Precise Table and X-ray Volume Imager (XVI). Users will be informed of the mandatory software upgrade upon its release (expected early 2014) which will mitigate the issue.

Device

Integrity R1.1, R3.0 and R3.1(digital linear accelerator)

Manufacturer

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