Events

Rappel de MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Imaxeon Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00426-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-11
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00426-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Bayer healthcare is recalling brackets used to mount the continuum pump on the iv pole distributed with non-wireless versions of medrad continuum mr infusion systems prior to march 2008. these brackets are being recalled because of a potential safety risk in the mri environment associated with locking pins which may become damaged and not restrain the pump from being attracted to the mri magnet.
  • Action
    Imaxeon is requesting their customers to inspect their bracket immediately. If a bracket has a damaged pin end users are advised to cease use immediately and remove from the MR scan room. Undamaged brackets should be inspected every time a Continuum Pump is installed or removed until a replacemnt bracket is supplied.

Device

MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008

Manufacturer

Imaxeon Pty Ltd
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DHTGA