Events

Recall of Panther and Panther Fusion Systems with 19-in monitor

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-2018-RN-00065-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00065-1
  • 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 been made aware that the touch screen monitor provided with certain panther and panther fusion systems has the potential for the glass panel to separate due to inadequate adhesion between the glass panel and the monitor. hologic has received 2 complaints where the glass panel separated from the panther monitor. to date, there have been no reports of injuries associated with this defect; however there is a potential risk that the glass panel may fall and injure an operator.
  • Action
    Hologic will contact affected customers to arrange for an interim solution to secure the glass panel to be installed. Subsequently, a replacement monitor with this issue corrected will be installed once made available.

Device

Panther and Panther Fusion Systems with 19-in monitor
  • Model / Serial
    Panther and Panther Fusion Systems with 19-in monitorProduct code: 902615Serial Nos: 2090002307 to 2090002532Manufactured between April 2017 and Nov 2017ARTG Number: 260039 (Gen-Probe Australia Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd