Events

Retiro De Equipo (Recall) de Ingenia, Intera and Achieva MR Systems on software version R5.1.1 and R5.1.2

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-00577-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-22
  • 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-00577-1
  • 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 problem can occur when the field of view of the clinical stations is below (more towards the feet) the light visor position. in such a situation an error is made in calculating the position information. this causes incorrect positioning of cross-reference lines on fused sagittal images.The cross reference lines of transversal images are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. the cross reference lines are correctly displayed on the unfused stations.
  • Acción
    Philips is advising end users to not perform planning or review planning of transversal images on fused sagittal images which were generated through MobiView post-processing. Philips field service engineers will disable the MobiView post processing software until a software update has been developed and distributed. This action has been closed-out on 12/02/2016.

Device

Ingenia, Intera and Achieva MR Systems on software version R5.1.1 and R5.1.2

Manufacturer

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