Events

Device Recall Mobius 3D 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mobius Medical Systems, LP 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
    77177
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2100-2017
  • 사례 시작날짜
    2015-02-23
  • 사례 출판 날짜
    2017-05-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155184
  • 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
    Mobius3d version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of mobius3d (1.5.0) and the prior version (1.4.2), where none should have been expected.
  • 조치
    The recalling firm sent an Advisory Notice letter dated February 23, 2015 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Mobius Medical Systems Customer Support at support@mobiusmed.com.

Device

Device Recall Mobius 3D
  • 모델명 / 제조번호(시리얼번호)
    Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
  • 제품 설명
    Mobius3D || Product Usage: || Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
  • Manufacturer
    Mobius Medical Systems, LP

Manufacturer

Mobius Medical Systems, LP
  • 제조사 주소
    Mobius Medical Systems, LP, 4615 Southwest Fwy Ste 330, Houston TX 77027-7106
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA