Events

Rappel de Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging 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-00881-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • 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-00881-1
  • 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
    Siemens recently detected a rubber isolator with unfavourable aging properties. the function of this rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. in rare cases, when unfavourable aging has occurred, the rubber isolator may break and cause loss of support for the rotate motor. this event could lead to a rupture of the drive belt which in turn could damage the gantry covers and make contact with the patient. the possibility of a serious injury does exist if the belt makes contact with the patient. siemens have not received any reports of injury with the symbia t or symbia lntevo camera systems as a result of this problem.
  • Action
    Customers are advised that they can continue to use the systems while waiting for the corrective action to be undertaken which includes new mounting plate with improved rubber components and a backup device to ensure trouble free operation in the future. If users are experiencing abnormal noise or vibration, they are advised to immediately discontinue use and asked to contact their service engineer. Users are also asked to ensure that the safety advisory is placed in the System Owner's Manual. This action has been closed-out on 15/07/2016.

Device

Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)
  • Modèle / numéro de série
    Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)Multiple catalogue numbers affectedARTG Number: 123883
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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