Events

Recall of Monaco (with the use of Elekta Motorised Wedges)

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-2017-RN-00051-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00051-1
  • 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
    An issue has been identified where the calculated dose from wedged beams can be assigned to the wrong beam. this can occur for a plan with at least two beams using the elekta motorised wedge. as a consequence, a geometric miss would result with the dose distribution not reflecting what is delivered to the patient.
  • Action
    As a temporary fix, Elekta is advising users to change the beam index numbers belonging to the two wedged beams, such that the index numbers are exchanged for these beams, then edit the wedge angle of one of the beams. The problem will resolve itself if a recalculation is forced after the beam numbers are edited and the wedge angle is modified, A permanent fix in the form of a software update is anticipated to be released by the end of May 2017.

Device

Monaco (with the use of Elekta Motorised Wedges)
  • Model / Serial
    Monaco (with the use of Elekta Motorised Wedges)Software versions: V 5.10.00 (including 5.10.01, 5.10.02)V 5.11.00 (including 5.11.01)V 5.20.00ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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