Events

Recall of Integrity

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
    22246
  • Event Initiated Date
    2017-11-10
  • 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
    The precise treatment table is equipped with sensors that achieve a high degree of reliability in the readout of the table position. in case of an undetected failure of one of these sensors, it is possible to get a positional error with the precise treatment table following automatic table movement when using xvi and mosaiq.
  • Action
    Software to be upgraded

Device

Integrity
  • Model / Serial
    Model: , Affected: All Integrity™ R1.2 and Integrity™ R3.2 systems with a Precise Treatment Table for ATM license option
  • Manufacturer
    Elekta Limited (England)

Manufacturer

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