Events

Rappel de ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hologic Australia Pty Ltd.

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
    RC-2016-RN-01040-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01040-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Hologic have identified that the lid of the atec canister may have cracks that are related to lost/no vacuum during an atec biopsy procedure.This issue can be discovered during the inspection of the canister during setup or via a system vacuum error when testing the eviva or atec biopsy needle. from customer complaints received to date there has not been any patient harm or other safety issue. however, the issue may prevent the system from enabling a procedure to continue.
  • Action
    Hologic is advising users to inspect stocks and quarantine all affected units. Hologic will arrange for affected stock to be recovered and replacement stock, or a credit note, to be issued.

Device

ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)
  • Modèle / numéro de série
    ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)Lot Number: 20150013ARTG Number: 215794
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd