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
    80252
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2290-2018
  • 사례 시작날짜
    2018-03-28
  • 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=164962
  • 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 dose calculation accuracy may in some situations be less than expected. the user must be aware in order to avoid incorrect dose calculations during treatment planning.
  • 조치
    On March 28, 2018, the firm issued a Field Safety Notice, Medical Device Correction letter to its affected customers. The firm instructed users to take the following actions: -Do not use MLC only collimated to set output factor corrections (OFCs) in beam modeling of Elekta Synergy machines with MLCi/MLCi2 or any other machine with the MLC closer to the source than both the x- and y-jaws. Always use ¿Jaws and MLC collimated¿. -Be aware that there is an error in the field measure calculation for machines with the MLC closer to the source than both the x- and y-jaws, and for machines with fixed jaws. Make sure to perform patient-specific QA before treatment delivery for treatment plans with fields where: 1) closed MLC leaves are positioned inside the jaw field and 2) the minimum static/dynamic tip gap is larger than 0.001 cm. Please educate planning staff and all users about this workaround. Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this information by replying to the notification email. This issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in June 2018 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this Field Safety Notice, all users must maintain awareness of this Field Safety Notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.

Device

Device Recall RayStation
  • 모델명 / 제조번호(시리얼번호)
    6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 and 7.0.0.19
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, VT, WA, WI.
  • 제품 설명
    RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 || Product Usage: 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. 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