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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00333-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-16
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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

Manufacturer