Events

Retiro De Equipo (Recall) de Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP 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-2016-RN-00066-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-15
  • 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-00066-1
  • 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 identified an issue due to hydrogen embrittlement of fasteners during manufacture of ct systems. it was determined the issue was due to trapped hydrogen introduced into the fastener during electroplating operations performed by a philips supplier. hydrogen embrittled fasteners can crack and fail suddenly when under stress. assessment of these fasteners determined that sufficient mitigations were in place such that a single-point failure did not exist. even should two fasteners fail for the same component, the occurrence of harm was determined to be less than remote. there have been no complaints associated with this issue, and no reports of injury or death.
  • Acción
    Philips will replace the affected service latch fasteners for the units in the field. Philips is advising customers that in the interim, the affected CT systems have been determined to be safe for continued use.

Device

Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems
  • Modelo / Serial
    Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP SystemsAffected Models:728306 – Brilliance iCT728311 – Brilliance iCT SP 728326 – Ingenuity CT728321 – Ingenuity Core728323 – Ingenuity Core128728317 – Ingenuity Flex728244 – Brilliance CT BigBore (Radiology)728243 – Brilliance CT BigBore (Oncology)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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