Events

Rappel de Siemens MR - MAGNETOM Concerto

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Siemens AG.

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
    19605
  • Date de mise en oeuvre de l'événement
    2015-12-23
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    The manufacture confirms that in some cases the quench lines for some superconducting magnets may have not been properly installed and wants to alert the users to check if the quench lines for their systems have been installed under safe conditions. siemens in new zealand will inspect all quench lines installed by siemens., quench lines are installed to vent helium gas in the event of a quench. (quenching refers to the events that occur when the liquid cryogens that cool the magnet coils boil off rapidly, which results in helium escaping very rapidly from the cryogen bath) in the rare event of a quench an improperly installed quench line may cause the helium gas to be blown directly into the magnet room or other areas.
  • Action
    Product to be modified

Device

Siemens MR - MAGNETOM Concerto
  • Modèle / numéro de série
    Model: , Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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