Events

Recall of Maquet Operating Theatre Lights

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
    18013
  • Event Initiated Date
    2015-02-04
  • 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
    Maquet has received some complaints of grinding on double (2 arms) or triple suspensions (3 arms), with paint possibly chipping from the junction between 2 arms. paint chips or particles can fall down from the suspension. this may happen during surgical procedures and paint chips may fall inside the surgical field of a patient.
  • Action
    Product to be modified

Device

Maquet Operating Theatre Lights
  • Model / Serial
    Model: PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range, Affected: Manufactured between March 2012 and July 2014
  • Manufacturer
    Maquet SA

Manufacturer

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