Events

Retiro De Equipo (Recall) de Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128The following CT products manufactured from 1 January 2006 to 30 June 2014 are potentially affected:Brilliance iCT/Brilliance iCT SPBrilliance Big Bore Oncology/Brilliance Big Bore RadiologyBrilliance 6/Brilliance 10/Brilliance16/Brilliance 16P/Brilliance 40/Brilliance 64Ingenuity CT/Ingenuity Core/Ingenuity Core128

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-2016-RN-01470-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-10
  • 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-2016-RN-01470-1
  • 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
    The patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans, due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected, there have been 2 occurrences of this failure mode in the past 10 years. this issue could result in undesired radiation due to multiple exposures of the same anatomical region caused by failed couch motion during ct scanning.
  • Acción
    A Philips Field Service Engineer will contact affected customers to schedule the updates. In the interim, customers are advised to follow the warning in the Instruction for Use: “During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.” If the patient table is not moving when it is commanded to move during CT scan, abort the scan by pressing the Pause button or Emergency stop actuator and call the local Philips representative.

Device

Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128The following CT pr...
  • Modelo / Serial
    Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128The following CT products manufactured from 1 January 2006 to 30 June 2014 are potentially affected:Brilliance iCT/Brilliance iCT SPBrilliance Big Bore Oncology/Brilliance Big Bore RadiologyBrilliance 6/Brilliance 10/Brilliance16/Brilliance 16P/Brilliance 40/Brilliance 64Ingenuity CT/Ingenuity Core/Ingenuity Core128 ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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