Events

Recall of Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical imaging systems)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-00172-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00172-1
  • 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
    A problem has been detected in the transperineal stepper with stand. the stand and the stepper have some sharp edges which can cause cuts to operator’s fingers or arms.
  • Action
    Philips is advising users to be aware that there are edges on the Stepper that can cause minor cuts until the repair is performed. A PhiIips/Invivo representative will organise a convenient time to perform the repair on site. This action has been closed-out on 06/07/2017.

Device

Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical im...
  • Model / Serial
    Uronav, Transperineal option - Stepper with Stand(stereotactic accessory for use with clinical imaging systems)Model Number: 980603113091Serial Numbers 1, 2 or 3ARTG Number: 230930
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA