Events

Device Recall Focal Radiation Treatment Planning System, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Computerized 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
    58233
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2572-2011
  • 사례 시작날짜
    2008-03-31
  • 사례 출판 날짜
    2011-06-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98778
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • 원인
    Focal: in absolute dose mode a beam with a port may be calculated with open normalization, with the result that the displayed dose reflects open normalization while the monitor units and qa plan reflect blocked normalization. this is particularly important when these beams also include compensators. the problem is detectable by looking at the delivered dose to the weight point in the patient as.
  • 조치
    Computerized Medical Systems Inc sent a "CUSTOMER ADVISORY" letter dated March 2008 to all affected customers. The letter describes the product, the problem and the actions to be taken. The firm provided a workaround for customers that states "Alternatively the plan can be imported directly into XIO". A copy of the Advisory was shipped with software within the affected range to those requesting a software upgrade. The issue was resolved in Focal Release 4.40.00 introduced in June 2008. The firm will send out a User Notice to all sites still running affected software to remind them that the issue resolution is available. For further questions, please call (403) 830-8023.

Device

Device Recall Focal Radiation Treatment Planning System,
  • 모델명 / 제조번호(시리얼번호)
    Focal Release 4.3.1 through 4.34.02
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and the countries of Albania, Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Peru, Portugal, Qatar, Romania, Russia, Serbia, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, and Venezuela.
  • 제품 설명
    Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02. || For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • 제조사 주소
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    USFDA