Events

Rappel de Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems)

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-2014-RN-00385-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-03
  • 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-2014-RN-00385-1
  • 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
    Gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localised melting of the endbell. this overheating has occurred only while units were being serviced by ge service engineers during repeated evaluation scanning. however, the issue could also occur in clinical mode.
  • Action
    While in clinical mode, If the operator is notified via user interface message that there are multiple X, Y, or Z gradient distortion faults they should monitor for smoke odours or evidence of overheating. If they detect either a smoke odour or evidence of overheating they should stop scanning immediately, remove the patient and call their GE Healthcare Service Representative. Scanning should not resume until the GE Healthcare service representative has confirmed the MRI scanner is functioning normally. GE Healthcare will correct all affected products.

Device

Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discov...
  • Modèle / numéro de série
    Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems) Multiple System IDsARTG Number: 108415
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd