Events

RayStation 5 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 RAYSEARCH LABORATORIES AB 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
    75633
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0720-2017
  • 사례 시작날짜
    2016-10-11
  • 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=150964
  • 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
    An error may occur with the display of dose computed on images other than the planning ct (auxiliary ct) when using multiple patient cases in raystation 5. if a ct image set with the same frame of reference as the displayed auxiliary ct set exists in another case, the dose display may be incorrect. when the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect. the dose value normally displayed in the upper left corner when pointing in the 2d view may be incorrect or missing.
  • 조치
    On October 11, 2016 RaySearch Laboratories distributed a Field Safety Notice, Medical Device Correction #13529 to customers via email. Customers were instructed to take caution when a patient has multiple cases. The following may be incorrect if there are image sets that shre the same Frame of Reference residing in different cases: *Display of evaluation dose computed on another CT image set and *Dose tracking fraction dose and deformed dose. Until a corrected version has been installed, all affected users must maintain awareness of this field safety notice. In these cases, the display of the dose values in the 2D view, including the dose value shown when pointing in the view, maximum dose position, dynamic isodose lines and dose grid display may be incorrect. Customers are encouraged to educate staff and all users about this. For regulatory information, please contact David Hedfors, at +46 8 510 530 12 or david.hedfors@raysearchlabs.com.

Device

RayStation 5
  • 모델명 / 제조번호(시리얼번호)
    Build No: "5.0.0.37, 5.0.1.11 or 5.0.2.35. Only 5.0.2.35 was distributed in the U.S.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA
  • 제품 설명
    Radiation Therapy Treatment Planning System || Product Usage: || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB