Events

Retiro De Equipo (Recall) de MobileDiagnost wDR 1 and 2(Mobile digital x-ray imaging system)

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-2015-RN-00524-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-19
  • 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-00524-1
  • 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 the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behaviour may not be possible. the system can be stopped by releasing the drive handle. proper behaviour is re-enabled when the system is rebooted. the hazard associated to this defect is the potential of a collision.
  • Acción
    Philips is preparing a field action kit, which will allow a Philips Service Engineer to replace the existing arrestor strap by a new arrestor with higher resistivity. This will reduce the electromagnetic pulse to a level, which is safe to not disturb the electronics. Users are advised not to try to correct unintended movement using the controls on the drive handle. Instead, stop the system immediately by releasing the drive handle entirely. Alternatively, the emergency button can be pressed. Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur. This action has been closed-out on 18/08/2016.

Device

MobileDiagnost wDR 1 and 2(Mobile digital x-ray imaging system)

Manufacturer

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