Events

Rappel de Affirm Lateral Arm Upright Biopsy Accessory(accessory to the Affirm Breast Biopsy Guidance System for Selenia Dimensions)

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-2017-RN-00988-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-30
  • 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-2017-RN-00988-1
  • 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 has received four complaints at the time of device installation that it was not possible to properly align small-diameter spring loaded core biopsy needles with the blue needle guide.The blue needle guide is used when a lateral left side approach is chosen for biopsy. investigation revealed a component issue that could impact needle alignment for all left approach lateral biopsy procedures. the impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue, is case-dependent and can be observed in the post-fire, post-biopsy, and specimen images when those are used during a procedure.The right side approach is not affected by the reported problem. to date, no patient injury has been reported.
  • Action
    1. A replacement part (blue needle guide) is available and Hologic will schedule an appointment for a field service engineer to install the new blue needle guide. 2. Complete, sign and return the supplied customer response form. Should you have any additional questions please contact Hologic. 3. Pass this letter on to all those who need to be aware within your organisation or to any facility where the potentially affected devices have been transferred.

Device

Affirm Lateral Arm Upright Biopsy Accessory(accessory to the Affirm Breast Biopsy Guidance System...
  • Modèle / numéro de série
    Affirm Lateral Arm Upright Biopsy Accessory(accessory to the Affirm Breast Biopsy Guidance System for Selenia Dimensions)Catalogue Number: ASY-09880ARTG Number: 281546
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd