Events

Device Recall CyberKnife Robotic Radiosurgery System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Accuray Incorporated 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
    61045
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1098-2012
  • 사례 시작날짜
    2012-01-16
  • 사례 출판 날짜
    2012-02-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107168
  • 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
    Accelerator, linear, medical - Product Code IYE
  • 원인
    An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4d ray tracing dose calculation algorithm. as a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
  • 조치
    Accuray sent an "URGENT DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides a work around to prevent the issue from happening. Contact Accuray Customer Support at 1-877-668-8667for questions regarding this notice.

Device

Device Recall CyberKnife Robotic Radiosurgery System
  • 모델명 / 제조번호(시리얼번호)
    Model number: P/N 025153
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Korea, Hong Kong, China, Canada, Turkey, India, Russia, Italy, France, Belgium, Poland, Germany, Netherlands, United Kingdom, Spain, Greece, Saudi Arabia, Switzerland, Ukraine, Czech Republic, and Japan.
  • 제품 설명
    CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation. || Accuray Incorporated, Sunnyvale, CA. || Treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • 제조사 주소
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • 제조사 모회사 (2017)
    Accuray Inc
  • Source
    USFDA