Events

Device Recall ViewRay Maridian System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Viewray Incorporated 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
    73550
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1309-2016
  • 사례 시작날짜
    2016-03-07
  • 사례 출판 날짜
    2016-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144447
  • 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
    When editing the isocenter or the couch position of the plan while in the treatment workflow (in the points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. as a result there is the potential to deliver dose to the initial isocenter rather than the new location.
  • 조치
    ViewRay sent an Urgent Device Correction letter dated March 7, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact ViewRay Customer Support at support@viewray.com or call the ViewRay Customer Support center at 855-286-8875.

Device

Device Recall ViewRay Maridian System
  • 모델명 / 제조번호(시리얼번호)
    Model number: 10000 Catalog/Part Number: 10000 Serial Numbers: 100, 101, 102, 104 & 105
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.
  • 제품 설명
    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated
  • Manufacturer
    Viewray Incorporated

Manufacturer

Viewray Incorporated
  • 제조사 주소
    Viewray Incorporated, 2 Thermo Fisher Way, Oakwood Village OH 44146-6536
  • 제조사 모회사 (2017)
    ViewRay, Inc.
  • Source
    USFDA