Pinnacle3, software versions 9.0, 9.2. 9.4, 9.6 (Radiation Treatment Planning System) 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-00975-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-09-09
  • 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 issue occurs under certain specific conditions where the user modifies a contour in a density-overridden rol (region of interest) with density set to a specific value in a computed plan. dose is subsequently invalidated and the user may recompute the dose. in this case, the density can be replaced by the ct number from the ct to density table when recomputed resulting in an incorrect dose, and the monitor units (mu) may then be much higher than originally planned. the user may continue, and save the plan with incorrect dose. when the plan is reopened, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.An incorrect radiation dose to the target or other structures could occur. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.
  • 조치
    Version 9.8 corrects the issue. Philips recommends that user always use version 9.8 or above for patient planning. Philips will provide version 9.8 to those customers that still have version 9.0, 9.2, 9.4 or 9.6. This action has been closed-out on 17/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Pinnacle3, software versions 9.0, 9.2. 9.4, 9.6 (Radiation Treatment Planning System)ARTG Number: 118156
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA