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
    22432
  • Event Initiated Date
    2018-01-12
  • 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 received complaints indicating that the central handle holder detaches easily from the cupola during use. it was determined that the cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.
  • Action
    Product to be exchanged

Device

Lights - Ardon
  • Model / Serial
    Model: 5214 MAQUET VOLISTA StanOP, TRIPOD and ACCESS Cupolas Surgical lights manufactured before July 2016., Affected:
  • Manufacturer
    Maquet SA

Manufacturer

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