Events

Recall of RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy treatment planning system)

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-2015-RN-00207-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00207-1
  • 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
    The issue concerns an error in dynamic multileaf collimator (dmlc) dose calculation for machines where the mlc is positioned above the jaws or the jaws are fixed. the output factor correction is computed from the irradiated area of the first control point but is applied to the entire beam. if the irradiated areas of the remaining control points are significantly different from the initial area, the output factor correction used for these control points will be incorrect.The maximum possible error in dose corresponds to the span of the output factor corrections of the beam model. for example, if the output factor corrections span 0.95-1.05, the maximum theoretical error is 10%, although for most plans, the error would be less.Machines that have backup jaw and the mlc below non-fixed jaws (e.G. varian linacs) and linacs that do not have backup jaw (e.G. siemens linacs and elekta agility) are not affected.
  • Action
    DMLC dose calculation for the affected linac types will be turned off in patch version 4.7.1 of RayStation, scheduled for market release April 2015. In the meantime, users are advised that if DMLC has been in use for affected linac types, review the beam models. The possible error in dose depends on the span of the output factor corrections. Deprecate any beam models that have been commissioned as DMLC capable for the affected linac types. Does not commission beam models as DMLC capable for the affected linac types.

Device

RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy t...
  • Model / Serial
    RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy treatment planning system)Software versions affected: 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14 and 4.7.0.15ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia