Events

Recall of Maquet H LED and PowerLED 700 Ambient Light Modules

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
    16434
  • Event Initiated Date
    2014-04-02
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Reason
    The ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. in some product models, this module is attached to the cupola through a set of 4 fixing tabs, which compose the plastic enclosure of the ambient light module. there is a potential risk of failure concerning the fixation of the module. it has been observed by some of our customers that one or several fixing tabs were broken, which led the ambient light module to detach, remaining attached by its wires only. the occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.
  • Action
    Product to be modified

Device

Maquet H LED and PowerLED 700 Ambient Light Modules
  • Model / Serial
    Model: Models: HLED700, PWD700, Affected: All units manufactured between Dec-2006 and Dec-2012
  • Manufacturer
    Maquet SA

Manufacturer

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