Events

Rappel de 3.0T GE 6-Channel Phased Array Flex Coil

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-2017-RN-01349-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-24
  • 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-2017-RN-01349-1
  • 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 with the 3.0t 6 channel flex coil used with the 3t mr750w surgical suite scanners. coil overheating can occur when the device is used in mode 2 setup. this could lead to a serious patient thermal injury.To date, there have been no injuries reported as a result of this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    GE Healthcare advised users to discontinue placing coil cables exiting towards the patient's feet. Users can continue to use Mode 1. GE Healthcare have corrected all affected units.

Device

3.0T GE 6-Channel Phased Array Flex Coil
  • Modèle / numéro de série
    3.0T GE 6-Channel Phased Array Flex CoilProduct Code: M0050SSARTG Number: 132706
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd