Events

Rappel de SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray system)

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-2014-RN-00457-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-2014-RN-00457-1
  • 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 mechanical function of the rubber damper, which is situated within the mounting assembly of the rotation motor, may potentially degrade over time and may impact stability. in rare cases, the rubber damper may break and cause the loosening of the mounting plates in the gantry. this event is not posing a hazard by itself but could lead to a rupture of the drive belt and subsequently to a scan abort. additionally the broken belt may damage the system cover so that the contact protection against rotating parts inside the gantry can’t be granted for the operator and patient.
  • Action
    Siemens is advising that there is no workaround for the user to minimise the potential risk of this issue. Siemens has developed a modification for the affected systems which is to replace the rotation motor mounting plate inside the gantry of the CT system by a new model. This new mounting plate includes significantly improved rubber dampers for the stability of the assembly. This action has been closed-out on 12/02/2016.

Device

SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body com...
  • Modèle / numéro de série
    SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray system)Catalogue numbers: 10045692, 10165566, 10165888, 10165977, 10415118, 10415119, 10415116 & 10415117ARTG number: 142119
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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