Events

Retiro De Equipo (Recall) de Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systems Manufactured beginning May 2009

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-01454-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-12-04
  • 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-2017-RN-01454-1
  • 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
    There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner’s main bearing may come loose. if this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. there is no potential for harm to the patient or operator due to this issue.
  • Acción
    Philips is advising users that they will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. (Reference: Field Correction FCO 72800690)

Device

Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 72833...
  • Modelo / Serial
    Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systemsManufactured beginning May 2009ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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