Events

Device Recall VARiS PRT Exchange 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
    45527
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0720-2008
  • 사례 시작날짜
    2007-10-02
  • 사례 출판 날짜
    2008-02-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65734
  • 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 Medical Accelerator - Product Code IYE
  • 원인
    Incorrect software validation- the arc treatment plans containing a dose dynamic mlc for imrt delivery that will not be recognized properly by the system. under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.
  • 조치
    An Urgent Medical Device Correction letter was distributed October 2, 2007, to all direct consignees, informing them that the ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery will not be recognized properly by the System. The firm provided corrective instructions and informed consignees that a product modification will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to upgrade the application.

Device

Device Recall VARiS PRT Exchange
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: All
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • 제조사 주소
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA