Events

Recall of Lights - Ardon

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Maquet SA.

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
    22736
  • Event Initiated Date
    2018-03-22
  • 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: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Reason
    The manufacturer has indentified a failure of the control keypad. this can result in the cupola not turning on or off. the manufacturer has received numerous complaints where this problem happened on 3 different keypad versions. the investigation which, included evaluation of worst-case scenarios, concluded that there is only a remote chance that the problem may cause injury.
  • Action
    Product to be modified

Device

Lights - Ardon
  • Model / Serial
    Model: VOLISTA 400 and VOLISTA 600 P/N ARD568801560, Affected:
  • Manufacturer
    Maquet SA

Manufacturer

Maquet SA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA