Events

Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan 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
    63110
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2378-2012
  • 사례 시작날짜
    2011-05-30
  • 사례 출판 날짜
    2012-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112573
  • 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
    This field notice concerns two behaviors of the shareplan (multiple fraction groups and depth offset) that may be unexpected and are not clearly described in the user manual. none of these behaviors have caused patient mistreatment or other incidents. however, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere.
  • 조치
    RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction dated May 30, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consigness were instructed to completely avoid affecting the erroneous behaviour, verify in TomoTherapy Hi-Art that the plans sent to TomoTherapy SharePlan 1.1 only have one single fraction group with a single fraction size,used for all fractions, and do not attempt to import treatment plans having more than one fraction size into the product. To completed avoid affecting the erroneous behaviour the user can either offset the measured curves before importing them into beam commissioning or add the depth offset tothe calibration depth. For further information consigness should contact RaySearch Laboratories AB Quality and Regulatory Affairs at +46 722 366 110 or the Tomo Therapy support at support@tomotherapy.com. North America 1 866 368 4807 Belgium 0800 38783 France 0805 631 565 Germany 0800 000 +541 Italy 800-986 399 Netherlands 0800 0201364 Spain 800 3000049 Switzerland 0800 001927 UK 0868 238 6035 China/Northern 10 800 712 1701 China/Southern 10800 120 1701 Hong Kong 800 967912 Japan 0044 22 132374 Singapore 800 1204683 South Korea 0079 81 4800 7204 All other locations + 1 608 824 2900 or +32 2 40 44 44

Device

Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan
  • 모델명 / 제조번호(시리얼번호)
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
  • 제품 설명
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. || Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB