Events

Retiro De Equipo (Recall) de Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall

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-01389-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-10-24
  • 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-2016-RN-01389-1
  • 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
    For the achieva 3.0t and ingenia 3.0t mr systems on sites with rear wall passive shielding, the thickness and location of shielding material must be installed according to requirements provided by philips. in cases where the requirements are not followed, the distance between the passive shielding rear wall and magnet could be insufficient. an insufficient distance leads to stronger attraction forces between the magnet and the passive shielding, which may lead to shearing of the magnet vibration pads. in a worst case scenario there may be displacement of the magnet, which could possibly result in harm (crushing risk) to persons inside the mr room and located between the magnet and passive shielding wall. to date there has been one overseas report of the magnet shifting with no harm to users or patients. displacement of a magnet can also result in image quality issues and mechanical fitting problems with the table. these functional issues affect the clinical usage of the mr system.
  • Acción
    Philips is advising customers that if the distance between magnet covers and finished rear wall is less than 1.3m, to contact Philips. In addition, Philips Field Service Engineers will be visiting all sites and checking this distance. If action is required, Philips will, as appropriate, replace the magnetic vibration pads and/or install seismic brackets. Depending on the circumstances, it may be advised that further clinical use of the MR system should not occur until after the installation corrections have been completed.

Device

Achieva 3.0T and Ingenia 3.0T MR Systems with passive shielding in the rear wall

Manufacturer

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