Events

Recall of Digital Accelerators with iViewGT or XVI

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-2017-RN-01480-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01480-1
  • 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 if the microswitch in the pcb assembly, solenoid limit switch of the middle arm is not set up correctly, it is possible to get an uncontrolled extension of mv or kv detector arms. it is possible that a collision with the extended arm can cause serious injury. when the detector arm is fully extended there is no risk.
  • Action
    Recommended User Action: Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions for use (IFU). iViewGT Elekta recommends that the detector panel is not opened or closed when the gantry is at 180° (±45°), especially when a patient is on the treatment table. The movement of the MV detector panel at these angles can disturb a patient if they are below the detector panel. XVI Elekta recommends that you do not open or close the detector arms when they are in a position above the patient. Distribute the supplied notice to all users of the system at your facility. Include a copy of the supplied notice with the system manuals. To acknowledge the receipt of this letter please complete the Confirmation of receipt form you receive from Elekta's automated distribution system. Return the form even if you no longer have the affected units at your site.

Device

Digital Accelerators with iViewGT or XVI

Manufacturer

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