Events

Beam Management System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ion Beam Applications S.A. 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
    79228
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0931-2018
  • 사례 시작날짜
    2017-10-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161705
  • 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, radiation therapy, charged-particle, medical - Product Code LHN
  • 원인
    Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
  • 조치
    IBA sent an Urgent Field Safety Notice dated October 19, 2017 , issued to customers stating the following: IBA recommends performing a check to detect the consequence of this potential power supply regulation issue on a regular basis (IBA recommends Monthly), see Annex 1 for details. IBA is developing a corrective action in order to reduce the hysteresis effect and detect magnet current overshoot. This solution will be deployed to all systems using JEMA analog power supply. This solution will be validated and deployed by April 2018. For further questions, please call (215) 972-7985

Device

Beam Management System
  • 모델명 / 제조번호(시리얼번호)
    PAT.003 (KR), PAT.006 (US)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the state of :FL
  • 제품 설명
    Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X || The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
  • Manufacturer
    Ion Beam Applications S.A.

Manufacturer

Ion Beam Applications S.A.
  • 제조사 주소
    Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
  • 제조사 모회사 (2017)
    Ion Beam Applications SA
  • Source
    USFDA