Events

Retiro De Equipo (Recall) de Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100 Wireless Type 5411

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AGFA HealthCare Australia.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00474-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00474-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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