Retiro De Equipo (Recall) de Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical imaging systems)

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-2017-RN-00172-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-02-03
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    A problem has been detected in the transperineal stepper with stand. the stand and the stepper have some sharp edges which can cause cuts to operator’s fingers or arms.
  • Acción
    Philips is advising users to be aware that there are edges on the Stepper that can cause minor cuts until the repair is performed. A PhiIips/Invivo representative will organise a convenient time to perform the repair on site. This action has been closed-out on 06/07/2017.

Device

  • Modelo / Serial
    Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical imaging systems)Model Number: 980603113091Serial Numbers 1, 2 or 3ARTG Number: 230930
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA