Rappel de ARTAIS ZEE BIPLANE MN

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
    19495
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-11
  • 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
    For artis systems in conjunction with the artis table: the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap ring is used to secure the bolt. in rare cases it was identified that the snap ring is not properly fixed. in case of a missing or wrongly installed snap ring the bolt could slide out of its base and the table top carriage could slide to the floor.

Device

  • Modèle / numéro de série
    Model Catalog: 10094143 (Lot serial: N/A); Model Catalog: 5904656 (Lot serial: N/A); Model Catalog: 7007755 (Lot serial: N/A); Model Catalog: 10848283 (Lot serial: N/A); Model Catalog: 10848282 (Lot serial: N/A); Model Catalog: 10848281 (Lot serial: N/A); Model Catalog: 10848280 (Lot serial: N/A); Model Catalog: 10094141 (Lot serial: N/A); Model Catalog: 7728392 (Lot serial: N/A); Model Catalog: 10280959 (Lot serial: N/A); Model Catalog: 10094135 (Lot serial: N/A); Model Catalog: 7412807 (Lot serial: N/A); Model Catalog: 5904466 (Lot serial: N/A); Model Catalog: 7555357 (Lot serial: N/A); Model Catalog: 7555373 (Lot serial: N/A); Model Catalog: 10848355 (Lot serial: N/A); Model Catalog: 10848354 (Lot serial: N/A); Model Catalog: 10848353 (Lot serial: N/A); Model Catalog: 5904441 (Lot serial: N/A); Model Catalog: 59 17 054 (Lot serial: N/A); Model Catalog: 5904433 (Lot serial: N/A); Model Catalog: 7008605 (Lot serial: N/A); Model Catalog: 5904649 (Lot serial: N/A); Model Catalog: 10094137 (Lot serial: N/A); M
  • Description du dispositif
    ARTAIS ZEE BIPLANE MN;AXIOM ARTIS BA;AXIOM ARTIS TA;ARTIS Q;AXIOM ARTIS DBC;ARTIS ZEEGO MULTI-AXIS;AXIOM ARTIS DFC;AXIOM ARTIS MP DIAGNOSTIC;AXIOM ARTIS DBA;AXIOM ARTIS DFA;ARTIS Q.ZEN;AXIOM ARTIS FA ALPHA;AXIOM ARTIS DBC MAGNETIC NAVIGATION;AXIOM ARTIS F
  • Manufacturer

Manufacturer

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