Events

Recall of Focal Release 4.80.00

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Elekta 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-2014-RN-01356-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01356-1
  • 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
    When a ct phantom is scanned and the images are transferred to focal, it is possible to sample the densities using the image statistics tool in focal. in the case where ct slice thickness is not the same as ct slice spacing the image statistics tool will report an incorrect hu. if the user bases their ct to ed file on this incorrect density information, dose calculation errors will result. the magnitude of the dose calculation error will be dependent on the magnitude of the hu error.This problem can only occur for sites who satisfy all of the below criteria:1. running focal release 4.80.00 2. using a ct slice spacing not equal to the ct slice thickness, and3. using the image statistics tool to quantify ct phantom densities which are then used to populate the ct to ed file.There have been no patient injuries reported.
  • Action
    As an immediate workaround:- The problem can be avoided by using a CT Slice Spacing equal to the CT Slice Thickness; and A software fix will be provided to rectify the defect as soon as possible. This action has been closed-out on 28/02/2018.

Device

Focal Release 4.80.00
  • Model / Serial
    Focal Release 4.80.00 ARTG Number: 186853
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DHTGA