Events

Retiro De Equipo (Recall) de SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens 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-2015-RN-00492-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-06-12
  • 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-2015-RN-00492-1
  • 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 three bolts used to fix the balance weight of the data measurement system (dms) may show signs of metal fatigue by producing an unusual noise whilst the gantry is in use and rotating. these bolts may potentially degrade over time and impact on stability of the balance weight. it should be noted that the rupture of a single bolt does not pose a hazard, however in the unlikely situation that all three bolts break, the dms balance weight is likely to drop into the gantry.This may cause serious patient injury and/or loss of scanned data and/or the machine rendered as out of service.No case reports have been received indicating patient injury.
  • Acción
    Service engineers will be replacing all the bolts holding the DMS balance weight with a new bolt design. In the interim, to minimise a potential hazard Siemens recommends for users to carefully monitor the noise generated during gantry rotation. Since bolts will deteriorate over time, the balance weight will slowly change its position, potentially leading to a new sound pattern. Should users become aware of a change to the typical noise of the scanner we recommend that you immediately stop operation and contact a Siemens service engineer. This action has been closed-out on 05/09/2016.

Device

SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008
  • Modelo / Serial
    SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008Catalogue/Lot number – 10165888, 10165977, 10415118, 10415119 systems manufactured before February 2008ARTG number: 142119
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA