Events

Rappel de SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00492-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-06-12
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00492-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008Catalogue/Lot number – 10165888, 10165977, 10415118, 10415119 systems manufactured before February 2008ARTG number: 142119
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA