Events

Recall of Leksell GammaPlan 11.1

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-2018-RN-00844-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00844-1
  • 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
    Elekta has identified that the margin tool in leksell gammaplan 11.1 systematically overestimates margin in certain areas of the volume. the root cause is that the margin algorithm calculates the expanded volume at a resolution limited to the original images resolution in the contours normal direction, resulting in an overestimation of the resulting margin volume in areas oblique to the contouring plane.
  • Action
    Elekta is requesting users consider implications of the described inaccuracy in use of the margin tool in Leksell GammaPlan.

Device

Leksell GammaPlan 11.1
  • Model / Serial
    Leksell GammaPlan 11.1ARTG Number: 158043(Elekta Pty Ltd - Radionuclide system, therapeutic, stereotactic radiosurgery, application program software)
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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