Events

Rappel de Samsung Digital X-Ray System GC80

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-2018-RN-00671-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-14
  • 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-2018-RN-00671-1
  • 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
    Two issues have been identified with the samsung digital x-ray system gc80:1. if the user does not completely close the detector tray in the table or stand, the system turns into the portable mode or the multi-portable mode and auto exposure control (aec) turns off. at this time, the screen of workstation and the screen of tube head unit (thu) show the portable mode on or the multi portable mode on and aec off. if the user makes an exposure without checking, it may be irradiated differently than intended and produce an unintended image.2. if the user incorrectly attempts to use a portable detector within the table detector or stand detector areas with the auto detector option switched on, the system may automatically select the table or stand detectors if the focal spot is met. in this situation, if the user attempts an exposure of the portable detector without checking which detector is selected, it may be irradiated differently than intended and produce an unintended image.
  • Action
    Samsung is advising users: 1. Carefully close the detector tray and check that the detector tray is completely closed. 2. When using a portable detector: a. ensure the portable detector is placed outside the table detector or stand detector area when the auto detector option is switched on; or b. switch off the auto detector option before exposing patients with a portable detector placed within the table or stand detector areas. 3. Always carefully check the screen of Workstation or the screen of THU before making an exposure, and be sure to check the Receptor (4), AEC mode (7,8), and the exposure condition (1,2,3,5,6,9,10,11,12). If the intended detector is not set, please select the detector to be used. Samsung is planning to release updated software (expected to be available 30 June 2018) to prevent the outlined issues occurring. Implementation of the software update will be carried out by Quantum Healthcare Pty Ltd.

Device

Samsung Digital X-Ray System GC80
  • Modèle / numéro de série
    Samsung Digital X-Ray System GC80ARTG Number: 224370(Samsung Electronics Australia - X-ray system, diagnostic, general-purpose, stationary, digital)
  • Manufacturer
    Samsung Electronics Australia Pty Ltd

Manufacturer

Samsung Electronics Australia Pty Ltd