Events

Device Recall Varian Ximatron CSeries Digital Imaging 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
    38376
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0213-2008
  • 사례 시작날짜
    2007-06-25
  • 사례 출판 날짜
    2007-11-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53505
  • 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
    Oncology Information System - Product Code KPQ
  • 원인
    Unexpected loss of treatement field add-ons (wedges, blocks, etc) during ximatron simulation. if an unapproved treatment field is created without an mlc, but with an add-on, the add on will be deleted without warning. if this is not detected and corrected, incorrect dose delivery will occur.
  • 조치
    The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem.

Device

Device Recall Varian Ximatron CSeries Digital Imaging
  • 모델명 / 제조번호(시리얼번호)
    Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---
  • 제품 설명
    Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
  • 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