Events

Rappel de Discovery MR450, MR750 and Optima MR450w MRI System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia 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-2013-RN-00885-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-19
  • 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-2013-RN-00885-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of discovery mr450, mr750 and optima mr450w product. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.
  • Action
    GE Healthcare is advising users that the system may continue to be used as normal even with the yellow foam protruding from the bore. Patient padding should be used as described in the Operating manuals and cleaning practices described in the Operating manuals should be followed. Patient padding will minimise contact with the foam and users are advised not to attempt to remove the foam. GE Healthcare will be installing a permanent cover over the foam in October 2013.

Device

Discovery MR450, MR750 and Optima MR450w MRI System

Manufacturer

GE Healthcare Australia Pty Ltd