Events

Device Recall XiO 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
    58260
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2595-2011
  • 사례 시작날짜
    2010-05-28
  • 사례 출판 날짜
    2011-06-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-04-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98827
  • 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
    Xio software: when digitally reconstructed radiographs (drrs) are generated in xio, and dicom is used to export the drrs (file-print-drr), the exported images are associated with the beams, but not the plan. the plan association had always been done manually by the user. this is functionality that has never been provided on xio. the problem occurs because xio is not storing a persistent dicom.
  • 조치
    Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to all affected customers. The notice indicated the problem, the clinical impact, and the workaround. The notice stated the sites will be notified when a solution is available. No date was given for the mailing or the solution.

Device

Device Recall XiO Radiation Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    XiO Release 4.0.2 and above
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
  • 제품 설명
    XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above || Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
  • 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