Events

Recall of Leksell Gamma Knife Perfexion (teletherapy device indicated 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-2014-RN-01107-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01107-1
  • 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
    In leksell gamma knife perfexion, the coordinate frame is fixed to the patient positioning system before treatment using a frame adapter. the coordinate frame is locked to the frame adapter via latches. the latches shall be turned ninety degrees and then locked. the manufacturer has got a report that the latches may be locked before they have been fully turned resulting in a poorly locked frame. investigations show that it may be possible to have a situation where the adapter latches can get stuck just above the coordinate frame surface and as a result the coordinate frame will not be fixed properly. if the coordinate frame is not correctly locked to the frame adapter a play may occur and possibly move the target from planned position by up to 0.5 mm. there is a potential of mistreatment due to the patient being incorrectly positioned.
  • Action
    Elekta has initiated more stringent measurements in manufacturing and will check/replace affected frame adapters in the field. Meanwhile, the users are advised the following: - Always assure that the plastic lever is only operated when at a right angle with the frame adapter. - Do not force the plastic lever in place if it meets significant resistance when turned. - Ensure that the plastic lever is completely flush with the frame adapter and that no angulations are present. This action has been closed-out on 06/09/2016.

Device

Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head ...
  • Model / Serial
    Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures)Frame Adapter Serial Numbers: FV001 to FV376ARTG Number: 182102 & 182943
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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