Events

Retiro De Equipo (Recall) de Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

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-00474-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-24
  • 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-00474-1
  • 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 have found two potential issues that may result in the subframe of the table top becoming free floating and causing unintended, horizontal motion. the two potential issues are:1. service latch may not be properly secured;2. service latch threaded rod may be fractured.There is a risk of serious injury to the patient and operator/technician as a result of the table top free floating. for the patient:· there is a potential for disconnection or movement of invasive medical devicesfor the operator/technician:· there is a potential for pinch point on the subframe; and a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward.
  • Acción
    Philips is advising their customers to stop using the system if horizontal free-floating couch motion is experienced during normal clinical use. The threaded rob will be replaced in all affected devices. This action has been closed-out on 12/02/2016.

Device

Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

Manufacturer

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