Events

Device Recall Eclipse Release 6.5 through 10 (build 7.3.10 through 10.0.34) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology Systems 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
    58969
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2780-2011
  • 사례 시작날짜
    2011-05-13
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100741
  • 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
    Radiation Treatment Planning System - Product Code MUJ
  • 원인
    In affected eclipse versions, user editing of the mlc leaf positions may not automatically invalidate calculated dose distributions.
  • 조치
    Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter included the description of the product, problem and recommendations and includes the release of a service pack in the future. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)

Device

Device Recall Eclipse Release 6.5 through 10 (build 7.3.10 through 10.0.34)
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: Nationwide (USA) and the country of Canada.
  • 제품 설명
    Eclipse Treatment Planning System; Release 6.5 through 10 || (build 7.3.10 through 10.0.34) || Varian Medical Systems, Inc. || Used to plan radiotherapy treatments for patients with Malignant or benign diseases. Plans beam irradiation with photon, electron and proton beams, as well as for internal radiation treatments.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

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