Events

Rappel de SIGNA Creator and SIGNA Explorer (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-2016-RN-01212-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-14
  • 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-01212-1
  • 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 function of rf power monitor is to monitor the rf amplifier output power, and detect if rf transmit power exceeding the predicted amount is generated. if the rf amplifier output power exceeds the predicted sar (specific absorption rate) amount, the rf power monitor will stop the scan. if the user performs a tps (transceiver processing and storage) reset during a patient scan, the rf power monitor will be disabled for the remainder of that patient scan. this would prevent the power monitor from detecting any subsequent failure of rf transmit function. these two failures together, could result in higher than expected thermal dose to the patient and higher than expected localised heating. there have been no failures of this type reported, and no injuries reported as a result of this issue.
  • Action
    GE Healthcare is advising users they may continue to use the system, but ensure the RF power monitor is re-enabled by initiating a new patient exam if a TPS reset is performed during a patient exam. A software upgrade will be installed as a permanent correction. This action has been closed-out on 18/05/2017.

Device

SIGNA Creator and SIGNA Explorer (MRI System)

Manufacturer

GE Healthcare Australia Pty Ltd