Events

Rappel de All Magnetom MRI systems with superconductive magnets

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 Healthcare Pty 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-01251-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-22
  • 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-01251-1
  • 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
    In some cases the quench lines of some superconducting magnets may not have been properly installed.Quench lines are installed to vent helium gas in the event of a quench (i.E., sudden loss of superconductivity when the temperature is raised). in the unlikely event that a quench were to occur, a damaged/inappropriately installed quench line could lead to a displacement of oxygen, cold burns and/or could pose a risk to users, patients or others if the helium gas is vented to a closed area inside a building.
  • Action
    The sponsor is advising users to contact their contract quench line installer (Siemens or third party) to perform a quench line inspection. In the interim, users are reminded that it is important to follow the guidelines outlined in the System Owner Manual, including ensuring that they have an emergency plan in place in the event helium gas escapes into the magnet room or other rooms. This action has been closed-out on 04/05/2017.

Device

All Magnetom MRI systems with superconductive magnets
  • Modèle / numéro de série
    All Magnetom MRI systems with superconductive magnetsVarious System NamesCatalogue Numbers: 10433372, 10432914, 7391167, 10849579, 10018165, 10352127, 10836666, 10836618, 10849582, 10849583, 10432915, 10849580, 7104719, 10655588, 7104594, 106557, 10018223, 7387074, 10018221 and 10276755ARTG Numbers: 98319, 144221, 98485, 154128 and 188470
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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