Events

Rappel de Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body 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-2012-RN-00949-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-14
  • 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-2012-RN-00949-1
  • 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
    When positioning the coil off centre in the left direction as it is used, for example, a hip and shoulder imaging and, in addition at an off centre position with respect to the head-foot direction, the coil can heat up on the area of the electronic housing (white plastic lids).To be more precise, heating may occur if each of the following conditions applies at the same time:- coil positioned off-center in head-foot direction by more than 5cm- coil at side position- application of higher rf power over several minutes.In that position, the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient.
  • Action
    Siemens is providing work around instructions for users to follow.

Device

Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)
  • Modèle / numéro de série
    Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)ARTG Number: 98485
  • Manufacturer
    Siemens Ltd

Manufacturer

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