Events

Recall of ONCENTRA Brachy version 3.x and 4.x

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

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-2015-RN-00448-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00448-1
  • 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
    In oncentra brachy (brachy planning (bp) module and plan analysis (pa) module) dose may be incorrectly calculated for regions of interest (rois) defined on a secondary image series when using specific registration methods. the magnitude of the dose calculation error depends on the registration transformation and can vary between 0 and 100% of the correct dose value.
  • Action
    A software patch is in development to correct this issue and is expected to be released end of November, 2015. Nucletron will work with their customers to implement the patch on affected devices. In the interim, end users are advised to resample Regions of Interest defined on a secondary image series onto the primary image series prior to dose evaluation. This action has been closed-out on 4/08/2016.

Device

ONCENTRA Brachy version 3.x and 4.x

Manufacturer

Nucletron Pty Limited