Events

Retiro De Equipo (Recall) de MobileDiagnost wDR (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-2014-RN-00959-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-05
  • 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-00959-1
  • 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
    If the system drives over insulated flooring or carpeting and then over an un-insulated (earthed) point or electrically grounded section, an electrostatic discharge (esd) spark can cause the system’s digital motion control (dmc) board to malfunction, resulting in unintended movement of the system e.G., an increase in speed or a change of direction. the hazard associated to this defect is the potential of a collision with the system.
  • Acción
    Users are provided with temporary workaround solutions to prevent the failure mode from occurring and if it occurs to stop the system immediately by releasing the drive handle entirely or by pressing the emergency button. A Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented that will allow to electrically isolate the DMC board from its frame by replacing the existing stainless steel bolts and washers with plastic spacers and nylon screws. This action has been closed-out on 1/06/2016.

Device

MobileDiagnost wDR (Mobile digital x-ray imaging system)

Manufacturer

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