Events

Field Safety Notices about quadrox-id adult - small adult oxygenators / pls-i oxygenators included in pls set circuits / hls module advanced oxygenators included in hls set advanced circuits

According to Agence Fédérale des Médicaments et des Produits de Santé, this field safety notices involved a device in Belgium that was produced by Maquet.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Belgium
  • Event Source
    AFMPS
  • Event Source URL
    https://www.afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/materiovigilance/fsn
  • Notes / Alerts
    Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, 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 data from the U.S. and Belgium.
  • Extra notes in the data

Device

quadrox-id adult - small adult oxygenators / pls-i oxygenators included in pls set circuits / hls...
  • Model / Serial
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AFMPS