Events

Device Recall TrueBeam and TrueBeam STx 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
    56346
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0106-2011
  • 사례 시작날짜
    2010-05-24
  • 사례 출판 날짜
    2010-10-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93278
  • 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
    Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "apply shift" and presses motion enable buttons. this can result in the actual patient position differing from that position indicated by the imaging application affecting poistion accuracy and precision.
  • 조치
    Varian Medical Systems issued an Urgent Medical Device Correction letter date dated May 24, 2010 to users identifying the affected device, the issue prompting the correction, and the actions to be taken by the user. Customers were asked to set couch tolerance values to small numbers, and for radiosurgical treatment tolerance values to be set to zero. A Varian representative will contact customers to schedule installation of a software version correcting the issue. US Customers can contact Varian at 1-888-827-4265,. European customers can contact Varian at +41 41 749 8844.

Device

Device Recall TrueBeam and TrueBeam STx
  • 모델명 / 제조번호(시리얼번호)
    H191001, H191003
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Two consignees, one in the US and one in Switzerland.
  • 제품 설명
    Varian brand TrueBeam and TrueBeam STx, || Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
  • 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