Events

Recall of MAQUET HLX 2004-5 DF

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

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
    22227
  • Event Initiated Date
    2017-11-08
  • 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
    From the manufacturer investigation it was concluded that the issue relates to a crack in the metal of the spring arms that has the potential to develop into a break. these paticular devices are over ten years old and even so the vast majority have not failed.
  • Action
    Product to be modified

Device

MAQUET HLX 2004-5 DF
  • Model / Serial
    Model: , Affected: HLX 3004-5 DF and XTEN DF Breaking of AC2000 spring arms
  • Manufacturer
    Maquet GmbH & Co KG

Manufacturer

Maquet GmbH & Co KG
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NZMMDSA