RaySearch RayStation 4.5, 4.7, 5, and 6(Radiation therapy treatment planning system) 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-2017-RN-00133-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-25
  • 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
    Due to a known error in nvidia graphics processing unit (gpu) card drivers, raysearch has prevented gpu based computations for very large computation problems. in an incorrect citrix xenapp configuration, the gpu may not be correctly identified and the erroneous calculation may be allowed. if this occurs, accelerated computation on gpu may give incorrect results for very large computation problems. dose computation will be affected if the dose grid contains more than 134217728 voxels for a photon plan or more than 67108864 voxels for a carbon ion plan. the main effect on calculated dose is that it may be incorrectly set to zero in parts of the dose grid. normally this would be highly detectable. there may also be some smaller impact on the dose in the non-zero region. deformable registration may be affected for large image sets. in a correct citrix xenapp and gpu installation by raysearch, the issue would not occur.
  • 조치
    Users are advised to verify the GPU settings on each of the Citrix XenApp servers according to the instructions in the customer letter. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. Add the RSL-D-61-320-EN-1.0 RayStation 4.5, 4.7, 5 and 6 Additional System Environment Acceptance Test Protocol GPU to the location of the RayStation manuals. The tests in the Additional System Environment Acceptance Test Protocol GPU must be performed in addition to the tests in the System Environment Acceptance Test Protocol to verify GPU computations whenever the hardware or software platform is changed. This action has been closed-out on 01/03/2018.

Device

  • 모델명 / 제조번호(시리얼번호)
    RaySearch RayStation 4.5, 4.7, 5, and 6(Radiation therapy treatment planning system)Build Numbers: 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24ARTG Number: 195288
  • Manufacturer

Manufacturer