Events

Retiro De Equipo (Recall) de Ingenuity TF PET/CT System with software version 4.0.3.26129

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-01314-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-10-17
  • 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-01314-1
  • 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 is advising of an issue with the qc baseline test. during the pet daily quality control (qc) baseline test, customers may see a popup message on the console stating “communications error. do you wish to continue?”, with the options of “ok” or “cancel”. answering either way may cause the daily qc to fail. in some cases, once this message appears, it will re-appear each time the daily qc is run.
  • Acción
    Where Daily QC is unable to be run due to a continual Communication Error, Philips is advising customers to contact their Philips Service Representative to resolve the issue. Philips will correct the issue in an upcoming software release.

Device

Ingenuity TF PET/CT System with software version 4.0.3.26129

Manufacturer

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