Events

Rappel de GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, & Signa Vibrant 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-2018-RN-00741-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-18
  • 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-2018-RN-00741-1
  • 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 identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. if the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
  • Action
    GE Healthcare are advising they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible. GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction. Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative immediately

Device

GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology...
  • Modèle / numéro de série
    GE Healthcare MRI SystemsTwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, & Signa Vibrant SystemsMultiple software configurationsARTG Number: 223115(GE Healthcare Australia - MRI system, full-body, superconducting magnet)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd