Events

Pinnacle3 Radiation Treatment Planning System, software version 9.0 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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-2014-RN-00291-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00291-1
  • 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
    When the user changes from one treatment machine to another, the jaw symmetry yes or no option may be set incorrectly to symmetric. when exported via dicom rt, multileaf collimator (mlc) and jaw positions agree with the pinnacle3 plan. however, because the jaw symmetry flag is set to yes, the record and verify (r&v;) system may force the jaws to be symmetric, thereby re-positioning the beam. the resulting beam on the r&v; system does not match the beam in pinnacle3 resulting in an incorrect dose to the target or other structure. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
  • 조치
    Philips is providing an update to software version 9.2 to all customers who have software version 9.0 installed. Until the update is applied, customers are advised to manually cick the button to set it to No if they observe the jaw symmetry is set to Yes inappropriately.

Device

Pinnacle3 Radiation Treatment Planning System, software version 9.0

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA