Events

Recall of Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therapy Treatment Planning System)Elekta Monaco rel. 3.10.00 through 3.20.00

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-2012-RN-00670-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00670-3
  • 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
    If the dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out:issue 1: the coordinates will be in dicom space, thus not matching the setup reference dialogue.Issue 2: the shift coordinates are reported incorrectly. the z coordinate should become dicom negative y and the y coordinate should become dicom z.Incorrect shift coordinates are generated based on issue 2 above. these shifts can lead to incorrect patient positioning prior to treatment position verification.
  • Action
    Customers to implement the work around instructions provided by the sponsor until the problem is resolved with the future release of a software patch. This action has been closed-out on 12/02/2016.

Device

Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therap...
  • Model / Serial
    Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therapy Treatment Planning System)Elekta Monaco rel. 3.10.00 through 3.20.00ARTG Number: 186856Focal rel. 4.64.00 through 4.70.00ARTG Number: 186853
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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