Events

Recall of Elekta X-Ray Volume Imaging System (XVI)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Elekta Limited (England).

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
    15809
  • Event Initiated Date
    2014-10-17
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Reason
    The xray volume imaging system (xvi) can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently., if patient and treatment table movements are not monitored ,and the automatic setup buttons are kept pressed ,the treatment table continues to move. it only stops when a touchguard activates. therefore this error can cause a collision between the patient and an external beam limiting device. if this error occurs with an external beam limiting device attached to the digital accelerator, it may cause fatal injury to the patient.
  • Action
    Software to be upgraded

Device

Elekta X-Ray Volume Imaging System (XVI)
  • Model / Serial
    Model: , Affected: , Software version: R4.5, R4.5.1, R4.6 to R5.0
  • Manufacturer
    Elekta Limited (England)

Manufacturer

Elekta Limited (England)
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA