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
    67511
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1308-2014
  • 사례 시작날짜
    2014-02-06
  • 사례 출판 날짜
    2014-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125643
  • 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
    Radiation Therapy Treatment Planning System - Product Code MUJ
  • 원인
    Raysearch laboratories has recalled raysearch ray station 4.0 software due to clinical dose calculation errors during radiation therapy.
  • 조치
    On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.

Device

Device Recall RayStation
  • 모델명 / 제조번호(시리얼번호)
    Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
  • 제품 설명
    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB