Events

Recall of Monaco and Focal (radiation treatment planning systems)

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-00896-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00896-1
  • 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 dicom exporting an arc plan (vmat, dynamic conformal or 3d static arcs) and using the composite field sequencing (cfs) feature, the dicom exported plan will not match the approved treatment plan.The problem occurs when the starting gantry angle of the second arc is exactly 180 degrees and the stop angle of first beam is greater than 180 degrees away from the start position of the second arc. cfs is designed to combine arcs into a single beam to streamline delivery. however, under these specific circumstances, the start and stop points for the arcs become corrupted.Sites affected will be those:1. running monaco release 3.20 and higher, and 2. with elekta or siemens linacs, and3. with any of the following licenses: vmat or dynamic conformal or 3d (static arcs), and4. using cfs when dicom exporting plans.Customers with focal releases 4.70 and 4.80 are also affected by this issue when focal is used with monaco and meet the criteria above.
  • Action
    Elekta is advising that to avoid the problem, do not use 180 degrees for the starting gantry angle of the second arc. Using 180.1 or 179.9 degrees as the starting gantry angle will completely avoid this issue. The problem will be resolved in updates to Monaco and Focal software i.e., Monaco 3.30, Monaco 5.00, and Focal 4.80. The expected release date is September 30, 2014. This action has been closed-out on 04/08/2016.

Device

Monaco and Focal (radiation treatment planning systems)
  • Model / Serial
    Monaco and Focal (radiation treatment planning systems)Monaco: versions 3.20.00 and higher Focal: versions 4.70 & 4.80 ARTG numbers: 215960 & 186853
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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