Events

Retiro De Equipo (Recall) de MammoDiagnost DR

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-01180-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-04
  • 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-2014-RN-01180-1
  • 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
    Philips has identified that the pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. the needle positioning device may move even with the safety switch engaged. if this occurs while the needle is inserted, it could lead to an unintended patient injury.
  • Acción
    A Philips Service representative will contact affected customers to schedule a service visit where the safety switch will be modified. In the interim Philips is reminding end users of the safety instructions in the user manual and recommending that the switch be inspected before every biopsy. This action has been closed-out on 17/08/2016.

Device

MammoDiagnost DR

Manufacturer

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