Events

Rappel de Siemens AXIOM Artis, Artis zee and Artis Q/Q

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
    19817
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • 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
    Due to a leak in the cooling system, fluids could seep into the equipment cabinet. this leak can occur sporadically in the affected systems., manufacturer initiated two field safety corrective actions (ax004/15/s und ax060/15/s) to address the issues with two different vendors for detector cooling devices. as the issues are identical, locally manufacturer sending both letters with one cover letter to all affected customers (this will prevent confusion among customers that have multiple systems and were required to receive both letters). each affected system will receive only one correction depending on the system type.
  • Action
    Product to be modified

Device

Siemens AXIOM Artis, Artis zee and Artis Q/Q
  • Modèle / numéro de série
    Model: 7555365,10094141,10094139,10094137,10094135,10280959,10848281,10848280,10848282,7413078,7412807,7008605,10848355,7728392,7555357,7727717, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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