Events

Device Recall RayStation 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
    61269
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1317-2012
  • 사례 시작날짜
    2011-12-06
  • 사례 출판 날짜
    2012-03-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107694
  • 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 issue was found with the dose calculation in the raystation 2.0, that could result in a potential overestimation of the dose. this could lead to the potential under-dosage of a patient.
  • 조치
    The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or freddie.cardel@raysearchlabs.com; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or niclas.borglund@raysearchlabs.com

Device

Device Recall RayStation
  • 모델명 / 제조번호(시리얼번호)
    Software version and build number is 2.0.0.15. Model number RayStation 2.0
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
  • 제품 설명
    RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. || RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com || Designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB