Events

Rappel de GE Healthcare MRI systems with superconducting magnets

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-2015-RN-00103-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-06
  • 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-2015-RN-00103-1
  • 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
    The mru (magnet rundown unit) is a critical safety component of the mr system that quenches the magnet (i.E., makes it non-magnetic) in emergency situations, such as those that can occur when a ferrous (metal) object is brought into the magnetic field.At certain sites, the mru may not be connected to the magnet. if the mru is disconnected, the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times. further, there is potential for a patient to sustain injury while trapped against the mr scanner.
  • Action
    GE Healthcare has provided instructions to assist end users to determine if the MRU is properly connected. If the MRU is not connected it is recommended that the MRI is not used and GE Healthcare is contacted immediately. GE Healthcare will inspect all affected systems and ensure the MRU is properly connected to the magnet. This will be performed by GE Healthcare service representative who will contact affected customers to arrange for this inspection and correction if needed. This action has been closed-out on 1/06/2016.

Device

GE Healthcare MRI systems with superconducting magnets

Manufacturer

GE Healthcare Australia Pty Ltd