Events

Rappel de Siemens Symbia E and e.cam Systems

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 Medical Solutions USA Inc.

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
    19940
  • Date de mise en oeuvre de l'événement
    2016-03-22
  • 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
    Collimator change activities may result in operator injury. a customer advisory notice is issued to advise customers that manufacturer is providing an addendum to the symbia e and e.Cam user manual with specific enhancements to the instructions for collimator change. incidents during collimator change may be avoided by operators properly following specified instructions. once the letter and addendum are provided to customers, it will further reduce the likelihood of the user error occurring during collimator change.
  • Action
    Instructions for use to be updated

Device

Siemens Symbia E and e.cam Systems

Manufacturer

Siemens Medical Solutions USA Inc
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA