Events

Rappel de GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T

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-00924-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-16
  • 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-00924-1
  • 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 has recently become aware of a potential safety issue with performing head or neck scans on the affected scanners. the currently displayed specific absorption rate (sar) values could be lower than the actual sar in the head and neck as predicted by sar modelling. the predicted head sar value from the modelling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.When the system transmits rf power using the whole body rf transmit coil, the sar value displayed on the system user interface, will be shown as equal to the whole body sar; therefore the sar delivered to the head could be higher than the displayed sar value. if patients receive higher than expected radio-frequency (rf) energy absorbed during mr imaging procedures, specifically for patients with mr conditional implants, then localised deep-tissue heating or thermal injury in the vicinity of implants could occur. there have been no injuries identified as a result of this issue.
  • Action
    GE Healthcare will correct all affected products. In the interim, for patients with MR conditional head and neck implants, customers are advised to use only the transmit/receive HEAD coil for conducting head and neck scans and to follow the implant’s labelling and instructions strictly. Also, do not scan patients with implants that have been labelled as MR Conditional with HEAD SAR requirements other than the IEC limit for 3.2 W/kg, as stated in the MR operator manual. For all patients, limit the length of scan protocols; specifically, do not scan any patient continuously without any break for longer than 100 minutes. As is the case for all MR imaging, follow Good Clinical Practices. This action has been closed-out on 07/09/2016.

Device

GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/...
  • Modèle / numéro de série
    GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T ARTG Number: 223115
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd