Events

Rappel de AurigaTM 30 and AurigaTM XL 4007

Selon Health Andorra, ce/cet/cette rappel concerne un dispositif en/au/aux/à Andorra qui a été fabriqué par Boston Scientific.

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
    ARS/2017/13156
  • Date
    2017-10-27
  • Pays de l'événement
    Andorra
  • Source de l'événement
    HA
  • URL de la source de l'événement
    https://www.salut.ad/alertes/alertes.php?_pagi_pg=24&data1=&data2=&tipus=PRODUCTES%20SANITARIS%20-%20Retirada&titol=
  • Notes / Alertes
    Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
  • Notes supplémentaires dans les données

Device

AurigaTM 30 and AurigaTM XL 4007
  • Modèle / numéro de série
  • Description du dispositif
    Warning scientific auriga-boston devices
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HA