Events

Recall of Apex (Multileaf collimator used with Elekta linear accelerators)

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-00083-2
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00083-2
  • 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
    If the apex collimator has not been correctly installed on the radiation head and the user use the touchguard button to override the touchguard inhibit and rotate the gantry, the apex collimator can disconnect form the radiation head. this can occur because a fault condition that shows that the apex collimator was not attached correctly is bypassed.
  • Action
    Users are requested to include additional safety information provided with the customer letter in the instructions for use. The safety information requests users to ensure that they do not override the touchguard inhibit or rotate the gantry after installing the Apex collimator. The safety information also informs users that the View Restrictions dialogue box may not show the touchguard inhibit restriction if there are other restrictions present.

Device

Apex (Multileaf collimator used with Elekta linear accelerators)
  • Model / Serial
    Apex (Multileaf collimator used with Elekta linear accelerators)ARTG Number: 186855
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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