Events

Rappel de AXIOM ARTIS DFC

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
    64866
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-09
  • 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
    For the below artis systems: -artis q systems with sw version vd11 and gigalix x-ray tubes -artis zee with sw versions vc21c vd11 and megalix cat+ x-ray tubes -axiom artis systems with sw version vb35e and megalix x-ray tubes the semi-automatic focus switch may in cases of a special type of defect in foci "small" and "micro" (if present) does not work as intended when pressing the footswitch multiple times. this special type of focus defect that causes the failure of the semi-automated focus switch becomes more likely as the service life of the x-ray tube increases.

Device

AXIOM ARTIS DFC
  • Modèle / numéro de série
    Model Catalog: 7412807 (Lot serial: ALL); Model Catalog: 7728392 (Lot serial: ALL); Model Catalog: 7555365 (Lot serial: ALL); Model Catalog: 10094142 (Lot serial: ALL); Model Catalog: 7008605 (Lot serial: ALL); Model Catalog: 10094135 (Lot serial: ALL); Model Catalog: 10094139 (Lot serial: ALL); Model Catalog: 10094137 (Lot serial: ALL); Model Catalog: 7555357 (Lot serial: ALL); Model Catalog: 10280959 (Lot serial: ALL); Model Catalog: 10848353 (Lot serial: ALL); Model Catalog: 10094141 (Lot serial: ALL); Model Catalog: 10848280 (Lot serial: ALL); Model Catalog: 10848281 (Lot serial: ALL); Model Catalog: 10848282 (Lot serial: ALL); Model Catalog: 10848283 (Lot serial: ALL); Model Catalog: 10848355 (Lot serial: ALL)
  • Description du dispositif
    AXIOM ARTIS DFC;AXIOM ARTIS DBC;AXIOM ARTIS DMP;AXIOM ARTIS ZEE FLOOR MN;AXIOM ARTIS DTA;ARTIS ZEE FLOOR;ARTIS ZEE MULTI-PURPOSE;ARTIS ZEE CEILING;AXIOM ARTIS DBA;ARTIS ZEEGO MULTI-AXIS;ARTIS Q.ZEN;ARTIS ZEE BIPLANE;ARTIS Q
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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