Events

Device Recall Radiation Therapy Treatment Planning System 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
    62967
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2324-2012
  • 사례 시작날짜
    2012-05-09
  • 사례 출판 날짜
    2012-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112152
  • 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
    The firm decided to recall when an issue was found with the dose calculation in raystation 2.5, raystation 2.5.1. the problem has not caused any patient mistreatment or other incidents. however, the user must be aware of this information to avoid incorrect dose calculations during treatment planning. the dose calculation is not correctly normalized in the unusual case of preventing the optimizatio.
  • 조치
    The firm, RaySearch Laboratories, sent an "Urgent Field Safety Notice, Medical Device Correction" letter dated May 9, 2012 to its customers. The letter describes the product, problem and actions to be taken. The letter informed the customers that the "workaround is to not use segment MU optimization" and that there "is in general no need to manually adjust the segment shapes to such an extent there is need for a separate optimization of the segment MU." Additionally, the customers were instructed -Do not uncheck the "Segment shapes" check box; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the noted software version numbers; and complete and return the Reply Form via fax to: RaySearch Americas Inc. at 888-501-7195; email: freddie.cardel@raysearchlabs.com and/or email to: Raysearch Laboratories AB at niclas.borglund@raysearchlabs.com. For further information and return of the Reply Form contact For the Americas: Director of Customer Support, RaySearch Americas at +1877 778 3849 or freddie.cardel@raysearchlabs.com; and For Europe, Asia and rest of the world: Director of Service, RaySearch Laboratories AB at +46 8 5450 6130 or niclas.borglund@raysearchlabs.com.

Device

Device Recall Radiation Therapy Treatment Planning System
  • 모델명 / 제조번호(시리얼번호)
    Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.
  • 제품 설명
    Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. || 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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB