Events

Rappel de Magnetom Spectra 3.0 T System (MRI 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-00023-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-01-15
  • 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-00023-1
  • 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
    Due to an isolated production issue, the body coil in the mri may possibly be fatigued after certain months of usage. this fatigue may potentially lead to the risk of overheating during delivery of rf energy due to underestimated specific absorption rate (sar) in extremely rare conditions for head, neck and shoulder examinations. siemens is not currently aware of any incidents related to this issue. however, the risk of overheating which may include tissue damage cannot be totally excluded, although the possibility of occurrence for serious injury is extremely low according to siemens' risk assessment.
  • Action
    Users are advised to undertake extra precautions during head, neck and shoulder scans ie, to advise patients to immediately communicate uncomfortable heating sensations so that the scan can be stopped. Body coils will be replaced as soon as possible for the systems which have been identified as having a slight beginning of aging. For the remaining potentially affected systems, tune up measurements and QA checks will be performed by the end of February 2014 to readjust the system if required to eliminate any immediate risk. All potentially affected body coils will be replaced by the end of May 2014.

Device

Magnetom Spectra 3.0 T System (MRI system)
  • Modèle / numéro de série
    Magnetom Spectra 3.0 T System (MRI system)Catalogue number: 10655588Serial numbers: 56031, 56029, 56019 & 56017ARTG number: 154128
  • Manufacturer
    Siemens Ltd

Manufacturer

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