Events

Rappel de AXIOM ARTIS FA ALPHA

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
    117057
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-09-14
  • 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
    It was identified that there is potential that a possible position sensor fault in the swivel base axis is not being detected by the system software. following the enabling of movement by the operator the c-arm system can unexpectedly move faster than normal. please note that the system will not move without movement being initiated by the operator however the speed at which it can move would be faster than normal.

Device

AXIOM ARTIS FA ALPHA
  • Modèle / numéro de série
    Model Catalog: 5904441 (Lot serial: ); Model Catalog: 5904656 (Lot serial: ); Model Catalog: 5904466 (Lot serial: ); Model Catalog: 7555357 (Lot serial: (FOR ALL DEVICES)); Model Catalog: 7555357 (Lot serial: VERSION VB23N OR VB35E); Model Catalog: 7555357 (Lot serial: SERIAL #S RUNNING SOFTWARE); Model Catalog: 5904649 (Lot serial: ); Model Catalog: 7412807 (Lot serial: ); Model Catalog: 7555365 (Lot serial: ); Model Catalog: 59 17 054 (Lot serial: ); Model Catalog: 59 04 433 (Lot serial: ); Model Catalog: 7728392 (Lot serial: ); Model Catalog: 7727717 (Lot serial: ); Model Catalog: 7555357 (Lot serial: THE AFFECTED SYSTEMS COVER ALL)
  • Description du dispositif
    AXIOM ARTIS FA ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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