Events

Device Recall Varian RV Software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems 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
    48661
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0164-2009
  • 사례 시작날짜
    2008-06-02
  • 사례 출판 날짜
    2008-10-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71829
  • 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
    Medical Linear Accelerator - Product Code IYE
  • 원인
    A malfunction within the varis software might result in a misadministration (underdose). the software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
  • 조치
    Recall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.

Device

Device Recall Varian RV Software
  • 모델명 / 제조번호(시리얼번호)
    H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
  • 제품 설명
    Varian RV Software || Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; || Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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