Events

Rappel de AXIOM ARTIS BA

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
    18818
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-07-27
  • Pays de l'événement
    Canada
  • 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
    Siemens is initiating a field corrective action as during routine surveillance activities it was identified that contaminants in the form of biomass can develop in the cooling system of artis systems which can result in damage to the pump system. biomass is developing in the ongoing life time of a system.

Device

AXIOM ARTIS BA
  • Modèle / numéro de série
    Model Catalog: 5904656 (Lot serial: 28022); Model Catalog: 7728392 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 5904656 (Lot serial: 28069); Model Catalog: 7007755 (Lot serial: 32070); Model Catalog: 10848283 (Lot serial: NA); Model Catalog: 10848282 (Lot serial: NA); Model Catalog: 10848281 (Lot serial: NA); Model Catalog: 10848280 (Lot serial: NA); Model Catalog: 10848355 (Lot serial: NA); Model Catalog: 10848353 (Lot serial: NA); Model Catalog: 5904441 (Lot serial: NA); Model Catalog: 10280959 (Lot serial: NA); Model Catalog: 5904466 (Lot serial: NA); Model Catalog: 7555357 (Lot serial: 53097); Model Catalog: 7555357 (Lot serial: 53081); Model Catalog: 7555357 (Lot serial: 53088); Model Catalog: 7555357 (Lot serial: 53101); Model Catalog: 5904656 (Lot serial: 28048); Model Catalog: 10094141 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 10094137 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 7727717 (Lot serial: 40033); Model Catalog: 7412807 (Lot serial: 35177); Model Catalog
  • Description du dispositif
    AXIOM ARTIS BA;ARTIS ZEE BIPLANE;AXIOM ARTIS TA;ARTIS Q;ARTIS Q.ZEN;AXIOM ARTIS FA ALPHA;ARTIS ZEEGO MULTI-AXIS;AXIOM ARTIS MP DIAGNOSTIC;AXIOM ARTIS DBA;ARTIS ZEE CEILING;AXIOM ARTIS DFC MAGNETIC NAVIGATION;AXIOM ARTIS DFC;AXIOM ARTIS FC;AXIOM ARTIS DBC
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC