Events

Varian Medical System TrueBeam 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
    58590
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2181-2011
  • 사례 시작날짜
    2011-04-05
  • 사례 출판 날짜
    2011-05-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99646
  • 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
    stereotactic radiosurgery and radiotherapy system - Product Code IYE
  • 원인
    Position sensor failure mode may result in an inaccurate position calculation. 1. the video returned by one of the two cameras inside the spectra is all white or all black, and the spectra stops tracking. or 2. certain video intensities are not available on one of the two cameras. the image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.
  • 조치
    Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.

Device

Varian Medical System TrueBeam
  • 모델명 / 제조번호(시리얼번호)
    Model number H19; Code numbers: H191011, H191019, H191027, H191033, H191012, H191021, H191028, H191037, H191013, H191023, H191030, H191043, H191016, H191025, H191031, H191045, H191018, H191026, H191032, H191047.  Affected NDA Serial numbers: P7-03112, P7-03174, P7-03221.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;
  • 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