Events

Retiro De Equipo (Recall) de DX-D 100 Digital Radiography X-Ray SystemAll Units

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-2014-RN-00674-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-25
  • 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-2014-RN-00674-1
  • 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
    When liquid comes in contact with the dx-d 100 touch screen, the device may incorrectly recognise this as user input altering device settings. capacitive touch screens rely on the electrical properties of the human body to enable users to operate the device with very light touches of a finger. however, when liquid comes in contact with the touch screen it may incorrectly recognise this as user input. for example, it could unexpectedly change the exposure settings.
  • Acción
    Users are advised that they must ensure their hands are dry before using the touch screen of the DX-D 100 because liquid residue may activate the action buttons on the touch screen. The following advice is provided in the customer letter in addition to referring users to the warning in the user manual:: - Do not operate touch screen monitor with wet hands. - Do not let liquids come in contact with the touch screen while the DXD 100 is powered on. - Always double check your parameter settings prior to exposing the patient.

Device

DX-D 100 Digital Radiography X-Ray SystemAll Units
  • Modelo / Serial
    DX-D 100 Digital Radiography X-Ray SystemAll UnitsARTG Number: 178856
  • Manufacturer
    AGFA HealthCare Australia

Manufacturer

AGFA HealthCare Australia