Events

Recall of Elekta Synergy, Base drive wheel assembly

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
    14629
  • Event Initiated Date
    2013-05-10
  • 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
    In a small number of digital accelerators, the gantry base wheel bolts have become loose and caused a malfunction. there have been a small number of digital accelerators where the joint between the drive gear and the gantry base drive wheel has become loose. this has lead to fatigue failure of the securing bolts.
  • Action
    Product to be modified

Device

Elekta Synergy, Base drive wheel assembly
  • Model / Serial
    Model: , Affected: Serial numbers 105345 to 151764 inclusive with XVI
  • Manufacturer
    Elekta Limited (England)

Manufacturer

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