Events

Recall of RayStation and RayPlan

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01436-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01436-1
  • 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
    It has been identified that an issue found with the electron dose calculation in raystation 3.5, raystation 4.0, raystation 4.5, raystation 4.7, raystation 5, raystation 6, rayplan 1 (raystation 4.9) and rayplan 2 (raystation 6). when calculating electron monte carlo dose with a very large number of histories, the dose calculation may be wrong.To the best of our knowledge, the issue has not caused any patient mistreatment or other incidents. however, the user must be aware of the following information to avoid incorrect dose calculations during beam modelling and treatment planning.Electron dose calculation in raystation uses a monte carlo dose engine, where a large number of particles are simulated. each simulated particle is called a history, adding to the simulated dose. the number of histories can be adjusted for each dose calculation.
  • Action
    Operators should inspect their product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice using the supplied Client Response Form. Operators should not use a number of histories above 6 million for electron dose calculation and should inspect all commissioned electron beam models for any applicator calculated with greater than 6 million histories. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017

Device

RayStation and RayPlan
  • Model / Serial
    RayStation and RayPlanModel or Catalogue: RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6)Multiple Lot and Serial numbersARTG number:195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia