Events

Rappel de Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AGFA HealthCare Australia.

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-00474-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-02
  • 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-00474-1
  • 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
    1) when using the dx-d 100 unit, sporadic unintended movements may be caused by an electrostatic discharge of the unit to the ground may occur.2) capacitive touch screens rely on the electrical properties of the human body to enable you to operate the device with very light touches of a finger. however, when liquid comes in contact with the touch screen it may incorrectly recognize this as user input. this issue was notified to users previously (tga ref:. rc-2014-rn-00674-1). a software fix to mitigate this issue will be implemented as part of this action.
  • Action
    1) A newly designed arrestor with a resistance of 1M ohm between frame and floor (ground) will be installed. Together with an update of Digital Motion Control (DMC) firmware this will prevent sporadic unintended movements. In the interim, users are advised that the unit is equipped with a safety switch in the drive handle and in case of an unintended movement, they should release the drive handle and the unit will stop. 2) A software update to change the behaviour of the touch screen so that holding the up or down button will change the value setting just a single step will limit the influence of an unintentional touch screen activation. In the interim, the operator must make sure that both hands and the touch screen are dry before utilizing the touch screen. The operator always should double check and verify the selected parameters and settings immediately before making an exposure (Ref. former letter (TGA ref:. RC-2014-RN-00674-1) and/or User Manual addendum communication). This action has been closed-out on 19/08/2016.

Device

Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411
  • Modèle / numéro de série
    Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411ARTG Number 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia