Events

Device Recall Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear 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
    58970
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2778-2011
  • 사례 시작날짜
    2011-05-13
  • 사례 출판 날짜
    2011-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100743
  • 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
    Linear Accelerator for Radiation Therapy System - Product Code IYE
  • 원인
    Some drive stand bolts may fail to meet mechanical specifications.
  • 조치
    Varian Medical Systems, Inc sent a "Urgent Medical Device Correction Urgent Field Safety Notice" letter dated May 13, 2011 to all affected customers. The letter included a description of product, problem and recommendations. This includes performing daily QA to detect isocenter shift and the use of independent patient position system. Customers are advised to discontinue its use if a shift is detected and to contact Varian Medical Systems for a replacement stand bolts and adjustment if necessary. For additional information please contact the Varian Oncology Help Desk at 888-VARIAN5 (888- 827-4265)

Device

Device Recall Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear
  • 모델명 / 제조번호(시리얼번호)
    H14, H19, H27, H29. Serial Numbers:  H140927 H191045 H294986 H295004 H295021 H295036 H140929 H191048 H294988 H295010 H295025 H295042 H140932 H191049 H294989 H295012 H295031 H295047 H140934 H191050 H294999 H295013 H295032 H295051 H191035 H272973 H295001 H295014 H295033 H295058 H191044 H294979 H295002 H295015 H295034 H295068
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: (USA) Nationwide including the states of PA. NJ, NY, MA, VA, TX, KS, FL, OH, SC, MN, CA, TN and NV; and the countries of Canada, Colombia, France, Italy, Japan, Netherlands and United Kingdom.
  • 제품 설명
    Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands || Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • 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