Events

Recall of iViewGT

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
    22332
  • Event Initiated Date
    2017-11-30
  • 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 manufacturer 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. when the detector arm is fully extended there is no risk.
  • Action
    Product to be modified

Device

iViewGT

Manufacturer

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