Events

Rappel de GC80 Diagnostic X-Ray 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 Samsung Electronics 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-2017-RN-00653-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-13
  • 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-2017-RN-00653-1
  • 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
    An incident had been reported in germany to samsung electronics on 15 dec 2016 where an image was obtained with over exposure during a thorax examination using the aec function. the exposure condition was: 125kv, 180mas.As a result of the malfunction of the aec, irradiation may not terminate properly which can cause exposure until the aec back up time which is set at 500msec by default. this can cause overexposure for users.
  • Action
    Samsung will be implementing a software update on affected units in early July 2017. In the interim, users are advised that they may continue to use the GC80 system, taking precaution of any possible network disconnection between the THU and WS. Users are requested to check 1) the THU connection status when using the system and 2) the THU connection before logging in after system booting. (Please refer to recall notification for images and further details).

Device

GC80 Diagnostic X-Ray system

Manufacturer

Samsung Electronics Australia Pty Ltd