Events

Retiro De Equipo (Recall) de DX-D 100 (Mobile diagnostic x-ray generator)

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-2013-RN-00560-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-04
  • 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-2013-RN-00560-1
  • 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
    Some agfa healthcare customers have encountered sporadic unintended movement when driving the dx-d 100 mobile unit.
  • Acción
    The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop. Customers are advised in the case of unintended movement not try to correct the units’ movement via the drive handle but release the drive handle immediately to stop the unit. If unintended movement is experienced, cusotmers are requested to notify Agfa Service. Affected units are required to be taken out of operation for correction.

Device

DX-D 100 (Mobile diagnostic x-ray generator)

Manufacturer

AGFA HealthCare Australia