Events

Recall of Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)

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-2016-RN-00410-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00410-1
  • 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
    There is a potential for incorrect mounting of the frame adapter to the coordinate frame. the latches of the frame adapter can be locked even if the locating pins of the frame adapter are not inserted into the corresponding holes in the coordinate frame. if the frame adapter is mounted incorrectly to the coordinate frame and this is not noticed by the user before treatment is started, dose will be delivered in the wrong place by up to 2cm.
  • Action
    Elekta is advising users that the frame adapter is safe to use provided that the Instructions for use are followed and conducted by a trained professional. It is of the highest importance that the frame adapter is mounted to the coordinate frame as described in the applicable Instruction for Use. The locating pins of the frame adapter shall be inserted into the corresponding holes in the coordinate frame before the three latches are locked. Also make sure that only trained personnel are involved in mounting the frame adapter. A field corrective action will be implemented to facilitate a correct mounting of the frame adapter.

Device

Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of he...
  • Model / Serial
    Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)ARTG Number: 182102
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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