Events

Recall of ATEC Canister (used with ATEC vacuum-assisted breast biopsy systems)

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-2016-RN-01040-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01040-1
  • 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 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)
  • Model / Serial
    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