Events

Recall of Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)

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-2013-RN-00401-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00401-1
  • 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 identified the following compliance issues:1. the audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate. 2. the total cumulative irradiation time display is not accurate. both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions.
  • Action
    Hologic is providing their customers with a revised version of the software. End users are requested to update their systems in accordance with the instructions provided with the update.

Device

Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)
  • Model / Serial
    Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)ARTG 158774
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd