Events

Retiro De Equipo (Recall) de GEMINI TF 64 PET/CT Systems, software versions 3.5.1 and 3.5.2.1

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-2013-RN-01326-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-16
  • 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-2013-RN-01326-1
  • 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 pet reconstruction server (prs) database may randomly lock up after the low dose ct acquisition is complete and will not allow the pet acquisition to begin, resulting in an unexpected incomplete study. if this condition occurs, users cannot remedy this issue and will require service interaction prior to the system being operational.
  • Acción
    Philips is contacting all affected customers to schedule service by a Field Service Engineer to install a software update to correct the problem. This action has been closed-out on 12/02/2016.

Device

GEMINI TF 64 PET/CT Systems, software versions 3.5.1 and 3.5.2.1

Manufacturer

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