Events

Recall of RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7) when used with photon Collapsed Cone dose calculation

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-2018-RN-00333-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00333-1
  • 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 field measure calculation may be incorrect for certain linac types. the error can affect beam commissioning of machines with the mlc closer to the source than both x- and y-jaws (e.G., elekta synergy with mlci/mlci2). the error can also affect the dose calculation in treatment planning with the same type of machines as well as machines with fixed jaws (e.G., elekta bm and vero), for some specific types of treatment plans.If the elekta synergy with mlci/mlci2, or a linac with similar collimator setup, is commissioned with measurement conditions ‘mlc only’, it may lead to errors in the output factor corrections (ofcs) and dose normalisation of the beam model. this is expected to result in a systematic error of 0 to 2% for most treatment plans and typical variations in the beam model ofcs.To date, there have been no reports of injury as a result of this issue.
  • Action
    Emergo is advising users: 1. Do not use ‘MLC only collimated’ to set output factor corrections (OFCs) in beam modelling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use ´Jaws and MLC collimated´.; and 2. Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm. This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018.

Device

RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7) when used with photon Collapsed Cone dose c...
  • Model / Serial
    RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)when used with photon Collapsed Cone dose calculationBuild Number: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, or 7.0.0.19ARTG Number: 195288(Emergo Asia Pacific T/a Emergo Australia - Radiation therapy treatment planning system)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia