Events

Device Recall Eclipse Treatment Planning System version 13.MR2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. 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
    76018
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0990-2017
  • 사례 시작날짜
    2016-12-02
  • 사례 출판 날짜
    2017-01-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151945
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    Modifications in version 13.6mr2 for contouring, smartadapt, and smartsegmentation workspaces resulted in contours not being saved consistently in eclipse. treatment planning system. the issue only occurs if certain conditions are fulfilled.
  • 조치
    Varian Medical Systems sent an Urgent Medical Device Correction Letter dated December 5, 2016 , that were sent to all 5 affected sites on December 5, 2016 by a trackable method. Letters advised users of the issue and the specific scenario that must take place for the issue to occur. Varian is investigating the issue and will provide a correction once it is available. We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions please call (650) 424-6833. Varian Oncology Help Desk Contact Information: Phone: +1.888.827.4265 Email: support @varian.com

Device

Device Recall Eclipse Treatment Planning System version 13.MR2
  • 모델명 / 제조번호(시리얼번호)
    Model # H48  Serial numbers: H48L574 H48L575 H48L576 H48L577 H48L578 H48L579 H48L580 H48L581 H48L582 H48L583 H48L584 H48L585 H48L586 H48L587 H482484 H487302 H48A587 H48D957 H480113 H480118 H481884 H481885 H481886 H481916 H481917 H484198 H484199 H488949 H48A680 H48A871 H48A872 H48A873 H48A874 H48A875 H48A876 H48A877 H48A878 H48A879 H48I531 H481195 H481236 H481237.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : NJ, TN. OR and FL.
  • 제품 설명
    Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] || Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients || with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron || and proton beams, as well as for internal irradiation (brachytherapy) treatments.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • 제조사 주소
    Varian Medical Systems, Inc., 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA