Events

Device Recall ProteusONE 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
    79229
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0943-2018
  • 사례 시작날짜
    2017-11-01
  • 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=161706
  • 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
    The internal configuration of the electrometers and the real-time control boards of the dekimo scanning controller is not checked before each patient treatment.
  • 조치
    The firm, IBA, sent an "Urgent Field Safety Notice" dated 10/31/2017 to customers on 10/31/2017. The notice described the product, problem and actions to be taken. stating the following: There is no specific recommendation for the user. IBA will provide an Internal User notice to the IBA site team, requesting the operator to select the Beam Delivery Point CGTR, by clicking on the BDP button, before each patient treatment preparation (see Annex 1 for details). This will begin the check of the internal configuration of all the elements of the Dekimo Scanning Controller. An updated system will be deployed on February 28, 2017. If you have any questions, contact Customer Complaints & Vigilance Director at Vigilance@iba-group.com or +32 10 203 787 or helpdesk at +32 2 507 20 81 (available 24/7).

Device

Device Recall ProteusONE
  • 모델명 / 제조번호(시리얼번호)
    SBF.101 (EU), SBF.105 (US)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to: MI only and country of: France.
  • 제품 설명
    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 || 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