Rappel de ARTIS ZEE CEILING

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    32427
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-10-02
  • Pays de l'événement
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    A particular component may not have been fitted correctly during the installation of some mavig portegra 2 systems (a ceiling suspension system). the component in question is not actively involved in the operation of the mavig portegra 2 system and its absense does not have an adverse effect on system function. the component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose leading to an adverse effect on the function and possibly becoming detached from the system.

Device

  • Modèle / numéro de série
    Model Catalog: 10094137 (Lot serial: ); Model Catalog: 7727717 (Lot serial: ); Model Catalog: 10094139 (Lot serial: ); Model Catalog: 7555365 (Lot serial: ); Model Catalog: 10094135 (Lot serial: ); Model Catalog: 7412807 (Lot serial: ); Model Catalog: 7728392 (Lot serial: ); Model Catalog: 7008605 (Lot serial: ); Model Catalog: 10280959 (Lot serial: ); Model Catalog: 59 17 054 (Lot serial: ); Model Catalog: 10094141 (Lot serial: ); Model Catalog: 7555357 (Lot serial: ALL SERIAL NUMBERS)
  • Description du dispositif
    ARTIS ZEE CEILING
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
  • Source
    HC