Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hologic Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00988-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00988-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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