Events

Retiro De Equipo (Recall) de MobileDiagnost wDR (mobile x-ray unit)

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

¿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-00034-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-17
  • 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-00034-1
  • 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
    Due to a potential electrical defect, encoder defect or software error the movement speed regulation of the mobilediagnost wdr does not work as intended. the device may move with increasing speed and/or in the wrong direction for up to 1.5 seconds after releasing the dead man switch (handle bar). additionally, there is the potential for batteries to overheat.
  • Acción
    Philips is advising customers to activate the emergency switch in the event of unintended movement which will immediately stop the MobileDiagnost wDR. Once a corrective action has been determined Philips will implement a fix to stop unintended movement. In addition, Philips will install a battery thermostat to the device.

Device

MobileDiagnost wDR (mobile x-ray unit)

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA