Events

Rappel de 3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)

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-2016-RN-00176-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-15
  • 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-2016-RN-00176-1
  • 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 gemflex coil manufactured by neocoil used with ge healthcare 3.0t scanners. part of the cable assembly may overheat when the device is used. there is a rare probability that this could result in minor burn injury in case of prolonged direct skin contact with the overheating part. so far there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users to ensure the user instructions are followed in regards to using proper padding to avoid all direct contact of the patient with the cable. The device can continue to be used while GE are implementing a permanent correction. This action has been closed-out on 23/05/2017.

Device

3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses f...
  • Modèle / numéro de série
    3.0T GEMflex Coil used with GE Healthcare 3.0T Scanners (used to transmit and receive RF pulses for diagnostic MRI procedures)Affected Products:3.0T GEM Flex Coil 16-L Array 5430008-23.0T GEM Flex Coil 16-M Array 5430008-33.0T GEM Flex Coil 16-S Array 5430008-43.0T GEM Flex Interface 5430008-5ARTG Number: 153134
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd